Handheld Radiofrequency Spectroscopy for Intraoperative Margin Assessment During Breast-Conserving Surgery

Size: px
Start display at page:

Download "Handheld Radiofrequency Spectroscopy for Intraoperative Margin Assessment During Breast-Conserving Surgery"

Transcription

1 Handheld Radiofrequency Spectroscopy for Intraoperative Margin Assessment During Breast-Conserving Surgery Assessment Program Volume 28, No. 4 August 2013 Executive Summary Background Breast-conserving surgery as part of the treatment of localized breast cancer is optimally achieved by attaining margins around the surgical resection that are free from tumor cells. Failure to achieve clear margins will often require additional surgery to re-excise breast tissue. Currently, histologic examination of excised tissues after completion of surgery is the only method of definitively determining whether clear margins were achieved. Methods such as specimen imaging, frozen section pathology, or touch-print cytology are either not optimally accurate, require considerable time and resources, or are not commonly available. MarginProbe is a device based on the principles of dielectric spectroscopy that characterizes tissue that the device comes in contact with. Cancer cells and normal breast tissues produce different signals. A handheld probe is applied to a small area of the resected surgical specimen and analyzes the tissue as to whether it is likely malignant or benign. Using the MarginProbe device is intended to increase the probability that the surgeon will achieve clear margins in the initial operation, thus, avoiding the need for a second surgery to excise more breast tissue. Objective The purpose of this Assessment is to evaluate the evidence regarding the use of handheld radiofrequency spectroscopy for intraoperative margin assessment (i.e., MarginProbe ) in improving health outcomes for patients undergoing breast-conserving surgery for localized breast cancer. Search Strategy We searched MEDLINE via PubMed in July 2013 using the search term MarginProbe. The web site of the U.S. Food and Drug Administration (FDA) was searched for documents relating to the MarginProbe device. Selection Criteria Due to changes in the classification algorithm of the device, only one study, presented in FDA documents, represents current performance and met selection criteria. BlueCross BlueShield Association An Association of Independent Blue Cross and Blue Shield Plans Main Results One clinical trial enrolled 596 patients randomized to either using the MarginProbe device with standard intraoperative assessment of margins or standard intraoperative assessment alone. The trial was designed with an endpoint called complete surgical resection, in which all positive margins on final pathologic examination in the final main lumpectomy specimen should have been additionally excised or noted if not excised. This outcome appears to be biased against the control arm of the study, and may not be fully clinically relevant because there was no requirement that the NOTICE OF PURPOSE: TEC Assessments are scientific opinions, provided solely for informational purposes. TEC Assessments should not be construed to suggest that the Blue Cross Blue Shield Association, Kaiser Permanente Medical Care Program or the TEC Program recommends, advocates, requires, encourages, or discourages any particular treatment, procedure, or service; any particular course of treatment, procedure, or service; or the payment or non-payment of the technology or technologies evaluated Blue Cross and Blue Shield Association. Reproduction without prior authorization is prohibited. 1

2 additional excision produce a clear surgical margin. This outcome was achieved in 71.8% of the MarginProbe arm and 22.4% of the control arm and was statistically significant. However, the trial design had several deficiencies which preclude full understanding of the results. How control patients were clinically evaluated for margin status is not completely described. The sequence of shavings either performed before randomization, in response to MarginProbe readings, or in response to clinical evaluation is not known, and thus, it is less than clear what can be attributed to MarginProbe assessment. The amount of tissue removed in the MarginProbe arm was greater than the control arm. After initial surgery, 31% of MarginProbe subjects had positive margins, and 42% of control subjects had positive margins. The re-excision rate was 23.8% in the MarginProbe group and 28.5% in the control group, a difference that was not statistically significant. The diagnostic characteristics of the MarginProbe device in detecting cancer in the main lumpectomy specimen, using pathologic examination as the reference standard and the surgical margin as the unit of analysis, showed that MarginProbe was 75.3% sensitive and 46.4% specific. Patient outcomes beyond the re-excision rate were not reported. Author s Conclusions and Comment The clinical trial of MarginProbe did not show a statistically significant difference in the only outcome having direct clinical relevance there was a 5% absolute difference in the re-excision rate. A lower re-excision rate would constitute a health benefit if the local recurrence rate is equivalent or less, an outcome not evaluated in this study. Therefore, the benefit of MarginProbe is uncertain due to the trial being insufficient to demonstrate improvement in the net health outcome. Use of MarginProbe results in more tissue being removed during the initial surgery, which is of uncertain health significance. The study shows that the diagnostic characteristics of MarginProbe in assessing presence of cancer at specimen margins is moderately sensitive and less than 50% specific. Positive tests have a 24% probability of being true positive, and 25% of positive margins will be missed by the device. The clinical trial assessed MarginProbe against a single comparative strategy that included gross inspection and radiologic imaging of the specimen. Based on the available evidence, the Blue Cross and Blue Shield Association Medical Advisory Panel (MAP) made the following judgments about whether handheld radiofrequency spectroscopy for intraoperative margin assessment during breast-conserving surgery (i.e., MarginProbe ) meets the Blue Cross and Blue Shield Association Technology Evaluation Center (TEC) criteria. 1. The technology must have final approval from the appropriate governmental regulatory bodies. In January 2013, MarginProbe received premarket application (PMA) approval from the U.S. Food and Drug Administration (FDA) as an adjunctive tool for identification of cancerous tissue at the margins of the main lumpectomy specimen. 2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes. The evidence does not permit conclusions concerning the effect of the technology on health outcomes. There is one randomized trial comparing use of MarginProbe to a standard-of-care assessment for surgical margins with its current classification algorithm. The principal outcome of the study was biased against the standard-of-care arm. There was an absolute reduction of 5% in re-excision rates in the MarginProbe arm, but it was not statistically significant. A greater amount of breast tissue was removed in the MarginProbe arm. No further outcomes were assessed beyond the re-excision rate. The diagnostic performance characteristics of the MarginProbe system showed moderate sensitivity of approximately 75% and poor specificity of 46% Blue Cross and Blue Shield Association. Reproduction without prior authorization is prohibited.

3 Handheld Radiofrequency Spectroscopy for Intraoperative Margin Assessment 3. The technology must improve the net health outcome. It has not been demonstrated that the net health outcome was improved. The re-excision rates were neither clinically meaningful nor statistically different between MarginProbe and standardof-care groups. No further outcomes beyond re-excision rates were evaluated in the trial. 4. The technology must be as beneficial as any established alternatives. MarginProbe has not been assessed in comparison to other techniques of intraoperative margin assessment such as frozen section and touch-print cytology. 5. The improvement must be attainable outside the investigational settings. Lacking evidence for improved net health outcome, whether they can be attained outside the investigational setting cannot be determined. Based on the above, handheld radiofrequency spectroscopy for intraoperative margin assessment during breast-conserving surgery (i.e., MarginProbe ) does not meet the TEC criteria. Contents Assessment Objective 4 Background 4 Methods 6 Formulation of the Assessment 7 Review of Evidence 7 Discussion 12 Summary of Application of the 13 Technology Evaluation Criteria References 15 Published in cooperation with Kaiser Foundation Health Plan and Southern California Permanente Medical Group. TEC Staff Contributors Author David H. Mark, M.D., M.P.H.; TEC Executive Director Naomi Aronson, Ph.D.; TEC Director, Technology Assessments Mark D. Grant, M.D., M.P.H.; Director, Clinical Science Services Kathleen M. Ziegler, Pharm.D.; Research/Editorial Staff Claudia J. Bonnell, B.S.N., M.L.S.; Kimberly L. Hines, M.S. Blue Cross and Blue Shield Association Medical Advisory Panel Trent T. Haywood, M.D., J.D. Chairman, Senior Vice President, Clinical Affairs/Medical Director, Blue Cross and Blue Shield Association; Steven N. Goodman, M.D., M.H.S., Ph.D. Scientific Advisor, Dean for Clinical and Translational Research, Stanford University School of Medicine, Professor, Departments of Medicine, Health Research and Policy; Mark A. Hlatky, M.D. Scientific Advisor, Professor of Health Research and Policy and of Medicine (Cardiovascular Medicine), Stanford University School of Medicine. Panel Members Peter C. Albertsen, M.D., Professor, Chief of Urology, and Residency Program Director, University of Connecticut Health Center; Sarah T. Corley, M.D., F.A.C.P., Chief Medical Officer, NexGen Healthcare Information Systems, Inc. American College of Physicians Appointee; Helen Darling, M.A., President, National Business Group on Health; Josef E. Fischer, M.D., F.A.C.S., William V. McDermott Professor of Surgery, Harvard Medical School American College of Surgeons Appointee; I. Craig Henderson, M.D., Adjunct Professor of Medicine, University of California, San Francisco; Jo Carol Hiatt, M.D., M.B.A., F.A.C.S., Chair, Inter-Regional New Technology Committee, Kaiser Permanente; Saira A. Jan, M.S., Pharm.D., Associate Clinical Professor, Ernest Mario School of Pharmacy, Rutgers, The State University of New Jersey, Residency Director and Director of Clinical Programs Pharmacy Management, Horizon Blue Cross and Blue Shield of New Jersey; Thomas Kowalski, R.Ph., Clinical Pharmacy Director, Blue Cross Blue Shield of Massachusetts; Lawrence Hong Lee, M.D., M.B.A., F.A.C.P., Vice President and Executive Medical Director for Quality and Provider Relations, Blue Cross and Blue Shield of Minnesota; Bernard Lo, M.D., Professor of Medicine and Director, Program in Medical Ethics, University of California, San Francisco; Randall E. Marcus, M.D., Charles H. Herndon Professor and Chairman, Department of Orthopaedic Surgery, Case Western Reserve University School of Medicine; Barbara J. McNeil, M.D., Ph.D., Ridley Watts Professor and Head of Health Care Policy, Harvard Medical School, Professor of Radiology, Brigham and Women s Hospital; William R. Phillips, M.D., M.P.H., Clinical Professor of Family Medicine, University of Washington American Academy of Family Physicians Appointee; Richard Rainey, M.D., Medical Director, Regence BlueShield of Idaho; Rita F. Redberg, M.D., M.Sc., F.A.C.C., Professor of Medicine and Director, Women s Cardiovascular Services, University of California San Francisco; Maren T. Scheuner, M.D., M.P.H., F.A.C.M.G., Chief, Medical Genetics, VA Greater Los Angeles Healthcare System; Associate Clinical Professor, Department of Medicine, David Geffen School of Medicine at UCLA, Affiliate Natural Scientist, RAND Corporation; J. Sanford Schwartz, M.D., F.A.C.P., Leon Hess Professor of Medicine and Health Management & Economics, School of Medicine and The Wharton School, University of Pennsylvania. CONFIDENTIAL: This document contains proprietary information that is intended solely for Blue Cross and Blue Shield Plans and other subscribers to the TEC Program. The contents of this document are not to be provided in any manner to any other parties without the express written consent of the Blue Cross and Blue Shield Association Blue Cross and Blue Shield Association. Reproduction without prior authorization is prohibited. 3

4 Assessment Objective Breast-conserving surgery as part of the treatment of localized breast cancer is optimally achieved by attaining margins around the surgical resection that are free from tumor cells. Failure to achieve clear margins will often require additional surgery to re-excise breast tissue. Handheld radiofrequency spectroscopy for intraoperative margin assessment (i.e., MarginProbe ) is a device that can detect tumor cells at the surface of the main lumpectomy specimen. It is intended for use in addition to standard intraoperative assessment to guide additional resection of tissue during breast-conserving surgery. The purpose of this Assessment is to evaluate the evidence regarding the use of MarginProbe in improving health outcomes for patients undergoing breast-conserving surgery for localized breast cancer. Background Margin Status and Outcomes of Breast-Conserving Surgery Breast-conserving surgery with radiation is considered equivalent to mastectomy in producing equivalent long-term survival for stage I or II breast cancer. Achieving clear surgical margins has been considered an important aspect of adequate breast-conserving surgery. Several studies have demonstrated an association between margin status and local recurrence rate. A meta-analysis by Houssami et al. (2010) showed an association (odds ratio 2.4 [95% CI: 1.9 to 3.0]) between local recurrence and margin status classified as positive or negative. Most studies of margin status and clinical outcome assess local recurrence rate as the outcome. At least one study reported an association between margin status and overall survival, but there was confounding caused by earlier stage of disease in patients with clear margins (Obedian and Haffty 2000). Beyond the generally agreed-upon prognostic significance of margins that are overtly positive, there is considerable controversy regarding the extent to which negative surgical margins are associated with better outcomes. According to the National Comprehensive Cancer Network (NCCN) guidelines on ductal carcinoma in situ, margins greater than 10 mm are widely considered as negative, but may be considered by some as excessive due to less than optimal cosmetic result (NCCN 2013). Margins less than 1 mm are considered inadequate, but margins less than 1 mm at boundaries with the skin or chest wall do not mandate re-excision. For infiltrating carcinoma, re-excision for positive margins is recommended, but in patients without an intraductal component and only a focally positive margin, it is acceptable to treat the patient with a radiation boost dose. Studies of hospital level and surgeon-specific re-excision rates show substantial variability. In a study by McCahill et al. (2012), re-excision rates were highest for patients with positive margins (86%), and declined as the margin increased. For patients with negative margins, re-excision rates varied between 0% and 70% among surgeons. However, assessment of margin status even after final pathologic examination has some degree of uncertainty or error. In a study by Kotwall et al. (2007), the margins of excisional biopsies (procedures not meant to be therapeutic breast-conserving procedures) were compared with the subsequent breast-conserving surgical findings. In patients with clear margins of various distance in their excisional biopsies, 8% of subjects with clear margins less than 1 mm, 15% of subjects with margins 1-2 mm, and 4% of subjects with margins greater than 2 mm had residual cancer in their breast-conserving surgery specimens. Thus, clear margins indicate a low (4% to 15%), but not zero, probability of residual cancer. Despite uncertainties in the literature, evidence would appear to support the standard practice of re-excising breast tissue in a second operation for patients who have positive margins in resected breast tissue. An American Society of Breast Surgeons position statement on breast cancer lumpectomy margins states that margins 1 mm or greater do not require reexcision, less than 1 mm or focally involved margins should be considered on a case-bycase basis, and that positive ink-positive margins require re-excision unless there are extenuating circumstances (American Society of Breast Surgeons 2013). Whether achieving margins greater than 2 mm has an effect in improving local recurrence or long-term outcome is uncertain. Intraoperative Assessment of Margins The reference standard for margin status is currently only achieved by pathologic examination of excised tissue performed after surgery Blue Cross and Blue Shield Association. Reproduction without prior authorization is prohibited.

5 Handheld Radiofrequency Spectroscopy for Intraoperative Margin Assessment Various techniques and methods have been evaluated to assist the surgeon in achieving clear margins during the initial operation. Some techniques do not actually assess the surgical margin, but attempt to more accurately identify the location of the tumor to the surgeon, thus increasing the probability of a clean margin by marking a better target for resection. Intraoperative ultrasound and cryoprobe-assisted localization are techniques to make the tumor more visible or more palpable to the surgeon (Pleijhuis et al. 2009). Intraoperative specimen radiography involves imaging the lumpectomy specimen and comparing the image of the specimen to the preoperative mammogram. If microcalcifications occur close to the edges of the specimen, the surgeon may decide to shave the associated cavity edges to create a larger margin from the calcifications. Frozen section analysis involves an immediate histological examination of excised tissue during the operation. It has been demonstrated that frozen section analysis results in additional tissue excision during the operation and results in low re-excision rates after definitive pathologic examination (Pliujhuis et al. 2009). However, it adds an average of 30 minutes to operating time, and its use is not routine. Intraoperative touch-preparation cytology is another technique in which cells at the surgical margin are directly examined. Studies report good diagnostic performance characteristics for identifying tumor at surgical margins, but it appears that it is also not in common use. MarginProbe Device The MarginProbe device is based on the principles of dielectric spectroscopy to characterize tissue that the device comes in contact with. A handheld probe with a measurement area of 7 mm generates radiofrequency electromagnetic fields at MHz that penetrate a few millimeters deep into tissues touching the probe. The signals reflected back to the device are collected and analyzed by the system. The resonance frequency and amplitude of the reflection change significantly with the change in tissue properties. When tissue of samples of pure cancer tissue and pure benign tissue are applied to the device, the frequency and amplitude of the signals produce a fairly pure separation of signal. In early developmental studies in which tissue samples in which known homogenous tissue samples were directly within the 7 mm footprint of the device, sensitivity and specificity of the device were high. When the measurement site contained at least 75% cancer, sensitivity was 100% and specificity was 87%. However, margins of actual lumpectomy specimens are not pure tissue samples. The signals from various tissues of known pathology have been subjected to analysis to produce a classification algorithm to optimize sensitivity and specificity for detecting tumor cells. The classification algorithm, however, does not allow a perfect distinction between malignant and benign tissue. The classification algorithm has been revised several times during the development of the product. It appears that only the study described in the evidence review section of this Assessment uses the latest classification algorithm; all prior studies used different classification algorithms and may not reflect the performance of the algorithm used in the pivotal study. For the user of the device, the classification algorithm produces a binary positive or negative result for a single test of a 7-mm diameter surface of the lumpectomy specimen. Each surface of the lumpectomy should be tested a minimum of 5 times and up to whatever maximum necessary to cover the entire surface of the particular margin. A margin is considered positive if one or more readings indicates positive with the device. Early Clinical Study of MarginProbe An early published study of clinical outcomes in a randomized trial of MarginProbe will be reported in this section of the Assessment because according to FDA documents, the classification algorithm used in this study is no longer used, and thus this study may not reflect current performance characteristics of the device. The study is similar in structure to the FDA pivotal study reviewed in the evidence section of this Assessment. In a study by Allweis et al. (2008), 300 patients undergoing breast-conserving surgery were randomized to either MarginProbe assessment plus standard margin assessment or standard margin assessment alone. Standard margin assessment was not specified in the study, but could include specimen imaging and microscopic pathological assessments. The principal outcome of the study was the intraoperative surgical resection (ISR) rate, which was defined as the proportion of patients in whom the main specimen surgical margins were positive who had all the 2013 Blue Cross and Blue Shield Association. Reproduction without prior authorization is prohibited. 5

6 margins surgically re-excised. Although reexcising the positive margin might produce a clean margin, it was not necessary in order to count it. In the study, 60% of patients with positive margins had all the positive margins re-excised in the MarginProbe group, whereas 41% of subjects with positive margins in the control group had all the positive margins re-excised (p=0.044). This translated ultimately to lower but not statistically significantly different reoperation rates (12.6% versus 18.6%, p=0.098). In the subgroup of patients with nonpalpable lesions, results were similar, and the reoperation rates were lower and statistically significant in the MarginProbe group (9.8% versus 20.9%). Excised tissue volume was slightly larger but not statistically significant in the MarginProbe group. The study is consistent with a possible benefit of MarginProbe in reducing the re-excision rate, but its results may not reflect current performance characteristics of the MarginProbe system. FDA Status. In January 2013, MarginProbe received premarket application (PMA) approval from the FDA. The Dune MarginProbe System is an adjunctive diagnostic tool for identification of cancerous tissue at the margins ( 1mm) of the main ex-vivo lumpectomy specimen following primary excision and is indicated for intraoperative use, in conjunction with standard methods (such as intraoperative imaging and palpation) in patients undergoing breast lumpectomy surgery for previously diagnosed breast cancer. The FDA labeling states that the Dune MarginProbe System should not be used (i.e., is contraindicated): n To replace standard tissue histopathology assessment n On ex-vivo lumpectomy specimens that have been exposed to saline, ultrasound gel or local anesthetic solutions. n On in-vivo tissue (i.e., it should not be used within the lumpectomy cavity) n On tissues other than breast tissue (i.e. it should not be used on sentinel lymph nodes) n Closer than 1.5 mm to a fine-needle localization guidewire Other warnings in the FDA labeling include warnings against its use in several types of patients, including those with known multicentric disease, bilateral disease, prior radiation, prior surgery, and others. Adverse effects listed included an extension in operating time, removal of healthy breast tissue, infection, bleeding, and local tissue damage. Methods Search Methods We searched MEDLINE via PubMed in July 2013 using the search term MarginProbe. The web site of the U.S. Food and Drug Administration (FDA) was searched for documents relating to the MarginProbe device. Study Selection There are relatively few published studies evaluating the MarginProbe device. In reviewing the documents concerning the trial evaluated by the FDA that led to approval, it is apparent that some of the earlier published studies have been used to refine the classification algorithms used by the system to determine test positivity. Only the FDA study reports the results of the MarginProbe device in its apparently most recent device and classification algorithm version. Thus, the only study selected for detailed review is the study described as the pivotal study in FDA documents (FDA 2012). Data Abstraction, Calculations, Quality Assessment Data were abstracted from various FDA documents by a single reviewer. Standard quality assessment tools were difficult to apply to this study, as it involved both a diagnostic device and subsequent intervention, and due to the nature of the device its use could not be blinded. Accordingly, we note possible biases and study limitations as necessary. Medical Advisory Panel Review This Assessment was initially reviewed by the Blue Cross and Blue Shield Association Medical Advisory Panel (MAP) on June 6, In order to maintain the timeliness of the scientific information in this Assessment, literature searches were performed subsequent to the Panel s review (see Search Methods ). An additional published article was found in the update search (Rivera et al. 2012). This study is the same as that reported as the pivotal trial in the FDA documents used in this Assessment and provides duplicate results Blue Cross and Blue Shield Association. Reproduction without prior authorization is prohibited.

7 Handheld Radiofrequency Spectroscopy for Intraoperative Margin Assessment Formulation of the Assessment Patient Indications MarginProbe is indicated for adjunctive evaluation of the main lumpectomy specimen in order to guide additional excision of breast tissue. In addition to the specific types of patients in the FDA label warnings that should be excluded from use, it should be noted that the inclusion criteria of the pivotal trial included only women with nonpalpable lesions. Results from the trial may not be generalizable to women with palpable lesions. It should also be noted that since MarginProbe evaluates tissue only in the main lumpectomy specimen, certain techniques of breast-conserving surgery contraindicate its use. Where the standard practice or planned procedure is to shave additional tissue beyond the main lumpectomy specimen at all margins, MarginProbe results do not reflect status of tissue directly adjacent to that remaining in the patient. Thus, MarginProbe is not indicated in cases where mandatory cavity shaving is carried out. Technologies to be Evaluated and Compared MarginProbe was used in a relatively specific manner and in relation to a comparative strategy in breast-conserving surgery in the study reviewed in this assessment. MarginProbe was used in patients after initial removal of the main lumpectomy specimen AND additional shavings judged as initially necessary. MarginProbe was then used to evaluate the main lumpectomy specimen, and the surgeon responded to MarginProbe results AND also to additional standard margin assessments including specimen radiography. Intraoperative histologic techniques such as frozen section or touch-print cytology were not used. This MarginProbe strategy was compared to a control strategy in which the main specimen plus additional shavings were initially performed, followed by additional shavings as indicated by additional standard margin assessments including specimen radiography. As in the MarginProbe strategy, frozen section or touch-print cytology were not used in the control arm. Health Outcomes n Breast-cancer-specific survival n Cancer recurrence n Re-excision For breast cancer, the most important health outcome is overall survival from the disease. MarginProbe is not intended to directly improve the surgical cure rates of cancer. Rather, it is intended to assist the initial surgical procedure so that equivalent or better outcomes can be achieved with less morbidity due to re-excision procedures. Thus, the principal outcome associated with use of the MarginProbe device is the re-excision rate. However, a lower re-excision rate can only be considered a positive health outcome if it is demonstrated or assumed that the local recurrence rate is equivalent or lower. A lower reexcision rate that ultimately results in higher local recurrence rates would simply indicate inadequate surgery. Lacking direct observation of these local recurrence rates, it is necessary that the patients undergo surgical procedures performed with at least an equivalent standard, and that they have a similar prognosis at the end of the initial sequence of care. The final pathologic margin status of the patient after initial breast-conserving surgery, although not a health outcome itself, is probably the major determinant of whether the patient will require re-excision, and might be considered a reasonable surrogate for a health outcome. When used as intended, MarginProbe is likely to result in additional breast tissue excision. Any adverse effects of MarginProbe would relate to the additional excision, which would include any adverse effects of additional operating time, cosmetic appearance of the breast, infection, and additional trauma to the breast and surrounding tissues. When not used as intended, for example, as the sole means of assessing surgical margins, it is possible that MarginProbe may produce worse outcomes for final surgical margins and/or re-excision rates. Specific Assessment Question Does use of MarginProbe as an adjunctive method to determining presence of cancer at the margins of lumpectomy specimens, improve health outcomes when compared to standard techniques of intraoperative margin assessment? Review of Evidence The evidence for this Assessment consists of the pivotal clinical trial evaluated in FDA documents which led to approval by the FDA in January 2013 (FDA 2012). Clinical studies prior 2013 Blue Cross and Blue Shield Association. Reproduction without prior authorization is prohibited. 7

8 to this trial were used to refine classification algorithms of the MarginProbe system; thus these earlier studies may not reflect current performance. This study reports the most relevant patient outcomes available for evaluating MarginProbe with the largest number of patients, including a large proportion of U.S. patients. In addition to clinical outcomes, the study allows assessments of diagnostic test performance of MarginProbe which will help inform judgments of its utility. FDA documents such as this summary of safety and effectiveness, in addition to showing results of analyses that are in general identical to those generated by the sponsors of the device, often include additional analysis requested by the FDA, analyses performed by FDA statisticians, and commentary indicating FDA analysts agreement or disagreement with any aspects of the sponsors analysis or claims. Pivotal Study Design and Outcomes The pivotal study compared surgical processes and short-term outcomes in patients in whom MarginProbe was used versus patients in whom MarginProbe was not used. The comparative strategy did not include intraoperative histologic techniques, but radiographic imaging of the main resection specimen was performed in addition to inspection of the resection specimen. A study flow chart is shown in Figure 1. 1 Patients enrolled in the trial first underwent excision of the main specimen. Additional shavings from the lumpectomy cavity could be performed before randomization to MarginProbe or standard-of-care (SOC) groups. Patients randomized to the MarginProbe arm at this point then had their main lumpectomy specimens tested with MarginProbe. Surgeons were then required to re-excise margins testing positive on MarginProbe or to document the positive test and note why a re-excision did not occur. A common reason was that the margin was close to skin, fascial layer, or chest wall. Patients in both study arms then underwent specimen imaging and other intraoperative assessment, after which additional shavings could be taken. The main specimen and all shavings were evaluated with complete histological assessment after surgery. Final margin status of the main specimen, as well as the patient, could be determined based on the histologic findings of the main specimen and all additional shavings. The performance of re-excision was based on the judgment of the treating surgeon. Figure 1. MarginProbe Pivotal Study Flow Chart Shaving option Shaving option Path report No repeat surgery Patient enrollment Main specimen excision Randomize SOC Arm Device use SOC+Device Arm Specimen imaging Shaving pathology + Main specimen pathology Repeat surgery Shaving option Shaving option Shaving option Blue Cross and Blue Shield Association. Reproduction without prior authorization is prohibited.

9 Handheld Radiofrequency Spectroscopy for Intraoperative Margin Assessment Several study outcomes were specified. Some of them are quite complex and require detailed description and comment. Table 1 shows the endpoints described as co-primary endpoints and confirmatory secondary endpoints. Other additional endpoints shown in the FDA Executive Summary will be defined and shown as necessary. Several issues regarding the design and outcomes of the study should be pointed out. Patients were randomized after initial removal of the main specimen and removal of additional tissue ( shavings ) on the judgment of the treating surgeon. If shavings were taken at this point, the surface of the main lumpectomy specimen no longer represents the interface of the specimen and tissue remaining in the patient at the margin where shavings were taken. This point is not addressed in the document. Several issues regarding these shavings taken before randomization are not fully discussed and raise some questions. It is also important to note that in the analysis of the study, although all shavings were evaluated histologically to assess the ultimate margin status of the patient, no information is available regarding whether shavings were performed pre-randomization, subsequent to testing with MarginProbe, or subsequent to standard margin assessment. The outcome of complete surgical resection (CSR) requires further discussion. Positive margins on final pathology were counted as CSR if they were excised or addressed, but there was no requirement that the additional shavings result in a clear margin. Thus, the re-excision performed in response to a true positive MarginProbe test or standard assessment, if it does not result in a clear margin, may not be clinically relevant. Noting but not re-excising a positive margin also is not clinically relevant. The part of the definition that counts addressing a positive test but not resecting (due to anatomic considerations) as a positive outcome for the MarginProbe arm appears to be biased against the control arm of the study. Information from the documents regarding how clinical assessment was carried out in the control group appears to be incomplete. It is unclear how diagnostic characteristics for the control group were determined. There is nothing in the document that states how a positive test is declared in the control arm. It appears that the only countable response in the control arm is a re-excision since there is no formal test to respond to; thus, this aspect of the outcome is biased. It is also unclear whether pre-randomization shavings are counted as being appropriate responses to a positive main specimen margin in either study arm. It is stated that a positive MarginProbe test required the surgeon to reexcise or address a positive test, but unclear if a pre-randomization shaving qualified as a valid re-excision or whether further excision was required. Table 1. Definition of Pivotal Trial Endpoints Co-primary Endpoints Complete surgical resection (CSR) Non-randomness Test Normalized Total Tissue Volume Definition All positive margins on the main specimen on final pathology re-excised or addressed (noted but not re-excised) Statistical test only applied to MarginProbe group to evaluate whether test positivity is not random Total tissue removed (main specimen, all shavings, plus additional procedures) as a % of baseline breast size Confirmatory Secondary End Points Total Tissue Volume Positive margin rate Re-lumpectomy procedure rate Total tissue removed (main specimen, all shavings, plus additional procedures) Percent of patients with at least one positive margin after initial surgical procedure ( using final pathology analysis of main specimen plus all shavings) Number of repeated ipsilateral breast conserving surgical procedures for each patient. Increase by 1 if there are additional subsequent lumpectomy procedures 2013 Blue Cross and Blue Shield Association. Reproduction without prior authorization is prohibited. 9

10 The study protocol offers 3 opportunities for shaving additional tissue in the MarginProbe arm and 2 opportunities for shaving in the control arm. The additional option to perform shavings may be in part responsible for more thorough excision of cancer tissue in the initial surgery. A non-randomness test was utilized to address this concern. 2 The principal outcome of CSR was criticized by the FDA because there was no accounting for false-positive MarginProbe readings. In patients with specimens who had no positive margins but had positive MarginProbe tests, additional healthy tissue would be resected. False-positive tests at different margins than some true-positive tests would result in unnecessary additional resection in addition to necessary additional excisions. The comparison of total quantity of tissue removed from each study group should at least, in part, address some of these concerns. Characteristics of Patients Enrolled in the Pivotal Study The pivotal study was a multicenter (21 sites) randomized study involving 596 patients assigned equally to the two arms of the study. Patients enrolled in the study met criteria mentioned in the FDA labeling, but also all had nonpalpable lesions which required imageguided localization. Some patient demographic and baseline breast cancer characteristics up to the point of randomization of the two groups are shown in Table 2. The characteristics of the patients and excised lesions appear to be generally similar. We could not find data on what proportion of patients had shavings taken before randomization. Outcomes of Pivotal Study Several outcomes were reported in the FDA Summary of Safety and Effectiveness relevant ones reported in Table 3. It is important to note that some results are reported using percentages or rates based on the subset of patients that had positive margins in the main specimen, and some results using all patients in the study. Although MarginProbe only has possible benefits in patients with positive margins in their main specimens, the negative consequences of false positives and subsequent unnecessary additional excisions can occur to all patients. In most cases, comparing rates using a denominator of all patients is the appropriate analysis. Of 298 subjects in the MarginProbe arm, 163 (55%) had positive margins by final pathology in the main specimen. Of 298 subjects in the control arm, 147 (49%) had positive margins by final pathology in the main specimen. This is probably a result that correlates with the slightly lower mean weight of specimens in the MarginProbe arm, a chance result since patients were randomized after the main specimen was excised. For the principal outcome of complete surgical resection, MarginProbe showed a rate of 71.8% versus 22.4% for controls, with positive margin subjects as the denominator, which is a Table 2. Baseline Patient and Breast Tumor Characteristics Characteristic MarginProbe, n=298 Control, n=298 Mean age % White % Black Mean BMI Preoperative Diagnosis (not all types listed) % Ductal carcinoma in situ % Mixed % Palpable lesion in excised specimen Mean weight of excised specimen (g) The non-randomness test described as [e]valuat[ing] the association between the margin level device output (positive or negative margin) and histology results (positive or negative) of main specimen obtained from an analysis accounting for correlated results within patients (either generalized linear mixed or estimating equations models) Blue Cross and Blue Shield Association. Reproduction without prior authorization is prohibited.

11 Handheld Radiofrequency Spectroscopy for Intraoperative Margin Assessment Table 3. Selected Results of Pivotal Trial Endpoint/ (denominator) ALL or PSS MarginProbe Control p-value or CI Complete Surgical Resection/PSS 71.8% 22.4% < Non-randomness Test/ALL Statistically significant detection of margins Not applicable Normalized Total Tissue Volume/ALL 15.1% 12.5% Meets noninferiority criteria (not specified) Total Tissue Volume/ALL 93cc 85cc Meets noninferiority criteria, 25cm Positive margin rate/all 31% 42% Re-excision procedure rate/pss 33.7% 46.9% 0.04 Re-excision procedure rate including mastectomy/all 23.8% 28.5% 0.32 ALL: all subjects in trial, 298 in each group PSS: positive specimen subjects, subset in each group with positive margins in main specimen on final pathology, n=163 in MarginProbe group, 147 in control group large magnitude of difference and statistically significant. Due to the previously mentioned bias involving positive margins noted but not resected, this outcome is biased. Greater volume of tissue resected on both a relative and absolute scale were greater in the MarginProbe group, but the data analysis presented only reports conclusions of a noninferiority analysis. The noninferiority margin for the normalized total tissue volume was not specified. More clinically relevant outcomes include the proportion of patients with positive margins on final pathology after surgery, which was 31% for the MarginProbe group and 42% in the control group (p=0.0082). It should be noted that some patients with positive margins in the MarginProbe group arise from subjects that did not have positive margins in their main specimen. However, due to false-positive MarginProbe readings, additional shavings were undertaken in which cancer tissue was found at the margin. Without these additional shavings taken in response to MarginProbe assessment, these patients would have been considered to have a clear margin. This occurrence reflects the uncertainty of final pathology in trying to ascertain whether all cancer tissue has been removed. It complicates the comparison of outcomes between the two groups because a measure usually considered a poor outcome such as a positive margin, in this case, is not due to inadequate surgery but inadvertent discovery of residual cancer due to falsepositive MarginProbe readings. Re-excision rates using all patients as the denominator showed about a 5% absolute reduction in the MarginProbe group, which was not statistically significant. The decision to re-operate was based on judgment of the surgeon based on patient and tumor characteristics and the totality of pathologic findings. It cannot be determined what factors led to the decision not to re-excise when the final pathologic determination showed positive margins. Limited analysis examining results in subgroups was reported. Most of the patients were from Israel, and subjects from Israel tended to show better results, in terms of the primary outcome, re-excision rates, and diagnostic performance, than subjects from the United States. No results were reported comparing results for different types of cancer, such has ductal carcinoma in situ and invasive cancers. Diagnostic Performance of MarginProbe on Main Specimens Although not a clinical outcome, the pivotal trial allows calculation of the diagnostic characteristics of MarginProbe in the ability to detect cancer at the margin of the main lumpectomy specimen. Since all margins of each specimen 2013 Blue Cross and Blue Shield Association. Reproduction without prior authorization is prohibited. 11

12 in the MarginProbe group required testing, and all margins of the main specimen were examined by histopathology, sensitivity and specificity and predictive values can be calculated. The sensitivity and specificity calculations represent the results of the test as it is to be used on a margin, with at least 5 readings over the total surface of the margin, and counting the test as positive if one or more readings are positive. Out of 1,788 margins with final histopathology, MarginProbe readings were valid or not missing in 1,750. Three-hundred twenty-seven margins were positive, and MarginProbe was positive in 246 for a sensitivity of 75.2%. Out of 1,423 negative margins, MarginProbe was negative in 660 for a specificity of 46.4%. These performance characteristics showing moderate sensitivity and poor specificity are consistent with better than random capability of the device in detecting positive margins, and was probably the statistical basis for the test being meeting a declared outcome of non-randomness. Given the 19% (327/1,750) prevalence of positive margins, the positive predictive value of a positive MarginProbe test for a margin is 24%. In another analysis (apparently performed or requested by FDA) in which the location of the positive margin was ignored, and the test was considered positive if any margin tested positive, MarginProbe was 96.3% sensitive but 8.9% specific. Although this test performance characteristic is less clinically relevant, what it does indicate is that in this study, the low specificity indicates that MarginProbe was positive for at least one margin in almost every patient in the study, even though the prevalence of at least one positive margin was 52%. The FDA Summary reports sensitivity and specificity values calculated by the device sponsor for the control arm of the study, which show apparently worse performance of standard margin assessment. However, it could not be determined how these diagnostic characteristics were calculated, as there was no specific designation during the study in which the control arm was considered to be undergoing a diagnostic test. It appears that only the behavior of taking additional shavings was recorded, and the timing of these shavings (pre-randomization or after clinical assessment) was not recorded. Other Adverse Effects Adverse effects between the study arms did not reveal any notable differences between treatment arms that could possibly be related to use of MarginProbe. Postoperative wound infections and breast abscess were rare or zero in both groups, and no other events could be plausibly related to MarginProbe. Discussion Although the MarginProbe device detects cancer cells in lumpectomy specimens statistically better than random, its performance characteristics show moderate sensitivity of 75% and poor specificity of 46% when evaluated on a per-margin basis. When used as an adjunct to standard margin assessment that uses specimen imaging, the clinical trial showed a statistically significantly higher proportion of patients with clear margins after initial surgery. However, this did not translate to a significantly different rate of patients undergoing second surgeries, although the absolute difference was 5%. It is not certain what factors lead the surgeons to not attempt a reoperation in all cases in which subjects did not have clear margins. In addition to not being statistically significant, it is not known whether the lower second surgery rate will result in equivalent or better long-term outcome rates such as the local recurrence rate. As mentioned previously, a lower re-excision rate is only a health benefit if it achieved without a higher local recurrence rate. Use of MarginProbe results in overall more tissue removed in surgery. The impact of this on cosmetic outcome and patient satisfaction is uncertain, and difficult to weigh against the potential for lower second surgery rates. The device sponsor designed their trial in with a specific outcome called Complete Surgical Resection, which effectively counts up truepositive MarginProbe readings, without considering whether an adequate or even any excision results from the true-positive test, and does not consider any consequences of false-positive tests. In this study, this outcome appears to be biased against the control arm of the study. Information in the study regarding clinical assessment and calculation of diagnostic performance in the control group was not completely reported Blue Cross and Blue Shield Association. Reproduction without prior authorization is prohibited.

13 Handheld Radiofrequency Spectroscopy for Intraoperative Margin Assessment It is important to reiterate that this clinical trial evaluated MarginProbe specifically as an adjunct to standard assessment of margins that did not include any intraoperative histologic techniques and that radiologic imaging and gross inspection of the main specimen was employed in addition to MarginProbe. It is unknown how MarginProbe would compare to other techniques of intraoperative margin assessment, nor how would it work if used without at least the standard techniques used in the pivotal study. Given the moderate sensitivity of the device of 75%, it is possible that outcomes might be worse without other methods. Surgeons should not abandon other methods of margin assessment when using MarginProbe. According to the labeling information, use of MarginProbe is contraindicated in some common situations. It should not be used when specimens have been exposed to ultrasound gel, saline, or local anesthetic solutions, or cryoassisted localization has been performed. It is uncertain how the device performs when other prior procedures, such as radiotracer injections or core needle biopsies, have been done. Future Research Future studies evaluating techniques for improving the performance of breast-conserving surgery by improving the rate at which margin-free resections are achieved and lowering the re-excision rate should aim at ultimately demonstrating effectiveness with rigorous randomized clinical trials. The pivotal trial of MarginProbe had critical flaws which prevented inferring effectiveness. The principal outcome of the study was designated in order to highlight true positive tests, regardless of the clinical relevance of those tests, and to disregard false-positive tests. Future studies of other devices or techniques should correct these flaws by careful consideration of the sequence of events and attention to bias. There should be sufficient statistical power to evaluate clinically important differences in relevant clinical outcomes such as the re-excision rate and the local recurrence rate. A standard protocol should be developed for all study arms, providing guidance on how surgeons should respond to the tests. Although demonstrating effectiveness in terms of cancer survival or metastatic rates is probably unreasonable, it might be possible to determine equivalency or superiority of local recurrence rates of different techniques. Summary of Application of the Technology Evaluation Criteria Based on the available evidence, the Blue Cross and Blue Shield Association Medical Advisory Panel (MAP) made the following judgments about whether handheld radiofrequency spectroscopy for intraoperative margin assessment during breast-conserving surgery (i.e., MarginProbe ) meets the Blue Cross and Blue Shield Association Technology Evaluation Center (TEC) criteria. 1. The technology must have final approval from the appropriate governmental regulatory bodies. In January 2013, MarginProbe received premarket application (PMA) approval from the U.S. Food and Drug Administration (FDA) as an adjunctive tool for identification of cancerous tissue at the margins of the main lumpectomy specimen. 2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes. The evidence does not permit conclusions concerning the effect of the technology on health outcomes. There is one randomized trial comparing use of MarginProbe to a standardof-care assessment for surgical margins with its current classification algorithm. The principal outcome of the study was biased against the standard-of-care arm. There was an absolute reduction of 5% in re-excision rates in the MarginProbe arm, but it was not statistically significant. A greater amount of breast tissue was removed in the MarginProbe arm. No further outcomes were assessed beyond the re-excision rate. The diagnostic performance characteristics of the MarginProbe system showed moderate sensitivity of approximately 75% and poor specificity of 46%. 3. The technology must improve the net health outcome. It has not been demonstrated that the net health outcome was improved. The re-excision rates were neither clinically meaningful nor statistically different between MarginProbe and standard-of-care groups. No further outcomes beyond re-excision rates were evaluated in the trial Blue Cross and Blue Shield Association. Reproduction without prior authorization is prohibited. 13

14 4. The technology must be as beneficial as any established alternatives. MarginProbe has not been assessed in comparison to other techniques of intraoperative margin assessment such as frozen section and touch-print cytology. 5. The improvement must be attainable outside the investigational settings. Lacking evidence for improved net health outcome, whether they can be attained outside the investigational setting cannot be determined. Based on the above, handheld radiofrequency spectroscopy for intraoperative margin assessment during breast-conserving surgery (i.e., MarginProbe ) does not meet the TEC criteria. NOTICE OF PURPOSE: TEC Assessments are scientific opinions, provided solely for informational purposes. TEC Assessments should not be construed to suggest that the Blue Cross Blue Shield Association, Kaiser Permanente Medical Care Program or the TEC Program recommends, advocates, requires, encourages, or discourages any particular treatment, procedure, or service; any particular course of treatment, procedure, or service; or the payment or non-payment of the technology or technologies evaluated. CONFIDENTIAL: This document contains proprietary information that is intended solely for Blue Cross and Blue Shield Plans and other subscribers to the TEC Program. The contents of this document are not to be provided in any manner to any other parties without the express written consent of the Blue Cross and Blue Shield Association Blue Cross and Blue Shield Association. Reproduction without prior authorization is prohibited.

15 Handheld Radiofrequency Spectroscopy for Intraoperative Margin Assessment References Allweis TM, Kaufman Z, Lelcuk S et al. (2008). A prospective, randomized, controlled, multicenter study of a real-time, intraoperative probe for positive margin detection in breast-conserving surgery. Am J Surg, 196: American Society of Breast Surgeons. (2013). Position statement on breast cancer lumpectomy margins. Accessed at https://www.breastsurgeons.org/statements/ PDF_Statements/Lumpectomy_Margins.pdf. Balch GC, Mithani SK, Simpson JF et al. (2005). Accuracy of intraoperative gross examination of surgical margin status in women undergoing partial mastectomy for breast malignancy. Am Surg, 71:22-7. Houssami N, Macaskill P, Marinovich ML et al. (2010). Meta-analysis of the impact of surgical margins on local recurrence in women with early-stage invasive breast cancer treated with breast-conserving therapy. Eur J Cancer, 46: Kotwall C, Ranson M, Stiles A et al. (2007). Relationship between initial margin status for invasive breast cancer and residual carcinoma after re-excision. Am Surg, 73: McCahill LE, Single RM, Aiello Bowles EJ et al. (2012). Variability in reexcision following breast conservation surgery. JAMA, 307: National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines). (2013). Breast Cancer. Version Available at Obedian E, Haffty BG. (2000). Negative margin status improves local control in conservatively managed breast cancer patients. Cancer J Sci Am, 6: Pleijhuis RG, Graafland M, de Vries J et al. (2009). Obtaining adequate surgical margins in breast-conserving therapy for patients with early-stage breast cancer: current modalities and future directions. Ann Surg Oncol, 16: Rivera RJ, Holmes DR, Tafra L. (2012). Analysis of the Impact of Intraoperative Margin Assessment with Adjunctive Use of MarginProbe versus Standard of Care on Tissue Volume Removed. Int J Surg Oncol, Vol. 2012: Epub 2012 Dec 26. U.S. Food and Drug Administration (FDA). (2012). Summary of safety and effectiveness data: MarginProbe System. Accessed at docs/pdf11/p110014b.pdf Blue Cross and Blue Shield Association. Reproduction without prior authorization is prohibited. 15

16 Technology Evaluation Center Blue Cross and Blue Shield Association 225 North Michigan Avenue Chicago, Illinois Registered marks of the Blue Cross and Blue Shield Association, an Association of Independent Blue Cross and Blue Shield Plans Registered trademark of Kaiser Permanente 2013 Blue Cross and Blue Shield Association. Reproduction without prior authorization is prohibited.

Rotation Specific Goals & Objectives: University Health Network-Princess Margaret Hospital/ Sunnybrook Breast/Melanoma

Rotation Specific Goals & Objectives: University Health Network-Princess Margaret Hospital/ Sunnybrook Breast/Melanoma Rotation Specific Goals & Objectives: University Health Network-Princess Margaret Hospital/ Sunnybrook Breast/Melanoma Medical Expert: Breast Rotation Specific Competencies/Objectives 1.0 Medical History

More information

Accelerated Radiotherapy after Breast-Conserving Surgery for Early Stage Breast Cancer

Accelerated Radiotherapy after Breast-Conserving Surgery for Early Stage Breast Cancer Technology Evaluation Center Accelerated Radiotherapy after Breast-Conserving Surgery for Early Stage Breast Cancer Assessment Program Volume 27, No. 6 February 2013 Executive Summary Background Radiation

More information

Current Status and Perspectives of Radiation Therapy for Breast Cancer

Current Status and Perspectives of Radiation Therapy for Breast Cancer Breast Cancer Current Status and Perspectives of Radiation Therapy for Breast Cancer JMAJ 45(10): 434 439, 2002 Masahiro HIRAOKA, Masaki KOKUBO, Chikako YAMAMOTO and Michihide MITSUMORI Department of Therapeutic

More information

PROPERTY OF ELSEVIER SAMPLE CONTENT - NOT FINAL

PROPERTY OF ELSEVIER SAMPLE CONTENT - NOT FINAL Oncoplastic breast conservation surgery Melvin J Silverstein C H A P T E R 5 Introduction Oncoplastic breast conservation surgery combines oncologic principles with plastic surgical techniques. But it

More information

Understanding ductal carcinoma in situ (DCIS) and deciding about treatment

Understanding ductal carcinoma in situ (DCIS) and deciding about treatment Understanding ductal carcinoma in situ (DCIS) and deciding about treatment Developed by National Breast and Ovarian Cancer Centre Funded by the Australian Government Department of Health and Ageing Understanding

More information

Corporate Medical Policy Brachytherapy Treatment of Breast Cancer

Corporate Medical Policy Brachytherapy Treatment of Breast Cancer Corporate Medical Policy Brachytherapy Treatment of Breast Cancer File Name: Origination: Last CAP Review: Next CAP Review: Last Review: brachytherapy_treatment_of_breast_cancer 7/1996 5/2015 5/2016 5/2015

More information

ductal carcinoma in situ (DCIS)

ductal carcinoma in situ (DCIS) Understanding ductal carcinoma in situ (DCIS) and deciding about treatment Understanding ductal carcinoma in situ (DCIS) and deciding about treatment Developed by National Breast and Ovarian Cancer Centre

More information

Surgical guidelines for the management of breast cancer

Surgical guidelines for the management of breast cancer Available online at www.sciencedirect.com EJSO xx (2009) S1eS22 www.ejso.com Guidelines Surgical guidelines for the management of breast cancer Contents Association of Breast Surgery at BASO 2009 Introduction...

More information

Corporate Medical Policy

Corporate Medical Policy Corporate Medical Policy File Name: Origination: Last CAP Review: Next CAP Review: Last Review: digital_breast_tomosynthesis 3/2011 6/2015 6/2016 12/2015 Description of Procedure or Service Conventional

More information

HAVE YOU BEEN NEWLY DIAGNOSED with DCIS?

HAVE YOU BEEN NEWLY DIAGNOSED with DCIS? HAVE YOU BEEN NEWLY DIAGNOSED with DCIS? Jen D. Mother and volunteer. Diagnosed with DCIS breast cancer in 2012. An educational guide prepared by Genomic Health This guide is designed to educate women

More information

Ductal Carcinoma in Situ (DCIS)

Ductal Carcinoma in Situ (DCIS) Diagnosis and Treatment of Patients with Primary and Metastatic Breast Cancer Ductal Carcinoma in Situ (DCIS) Ductal Carcinoma in Situ DCIS Version 2002: Gerber Version 2003 2009: Audretsch / Brunnert

More information

Understanding INTRABEAM Intraoperative Radiation Therapy for Breast Cancer A patient guide

Understanding INTRABEAM Intraoperative Radiation Therapy for Breast Cancer A patient guide Understanding INTRABEAM Intraoperative Radiation Therapy for Breast Cancer A patient guide A diagnosis of breast cancer is never easy, but today there are more treatment options than ever before. A breast

More information

OBJECTIVES By the end of this segment, the community participant will be able to:

OBJECTIVES By the end of this segment, the community participant will be able to: Cancer 101: Cancer Diagnosis and Staging Linda U. Krebs, RN, PhD, AOCN, FAAN OCEAN Native Navigators and the Cancer Continuum (NNACC) (NCMHD R24MD002811) Cancer 101: Diagnosis & Staging (Watanabe-Galloway

More information

Breast Cancer: from bedside and grossing room to diagnoses and beyond. Adriana Corben, M.D.

Breast Cancer: from bedside and grossing room to diagnoses and beyond. Adriana Corben, M.D. Breast Cancer: from bedside and grossing room to diagnoses and beyond Adriana Corben, M.D. About breast anatomy Breasts are special organs that develop in women during puberty when female hormones are

More information

See MP/H rules on the slides if you do not have your manual.

See MP/H rules on the slides if you do not have your manual. Quiz 1 1. Which of the following statements about the incidence of melanoma in the US over the last 30 years is true? a. Melanoma incidences have been going down for both men and women. b. Melanoma incidences

More information

Prostate Cancer. Treatments as unique as you are

Prostate Cancer. Treatments as unique as you are Prostate Cancer Treatments as unique as you are UCLA Prostate Cancer Program Prostate cancer is the second most common cancer among men. The UCLA Prostate Cancer Program brings together the elements essential

More information

FDA Review. Hologic Selenia Dimensions 3D System with C-View Software Module

FDA Review. Hologic Selenia Dimensions 3D System with C-View Software Module Radiology Advisory Panel Meeting Hologic Selenia Dimensions 3D System with C-View Software Module FDA Review Robert Ochs, PhD Branch Chief Mammography, Ultrasound, and Imaging Software Branch Division

More information

Breast Cancer. CSC Cancer Experience Registry Member, breast cancer

Breast Cancer. CSC Cancer Experience Registry Member, breast cancer ESSENTIALS Breast Cancer Take things one step at a time. Try not to be overwhelmed by the tidal wave of technical information coming your way. Finally you know your body best; you have to be your own advocate.

More information

Understanding your pathology report

Understanding your pathology report Understanding your pathology report 2 Contents Contents Introduction 3 What is a pathology report? 3 Waiting for your results 4 What s in a pathology report? 4 Information about your breast cancer 5 What

More information

Ask Us About Clinical Trials

Ask Us About Clinical Trials Ask Us About Clinical Trials Clinical Trials and You. Our specialists and researchers are at the forefront of their fields and are leading the way in developing new therapies and procedures for diagnosing

More information

Evaluation and Management of the Breast Mass. Gary Dunnington,, M.D. Department of Surgery Internal Medicine Ambulatory Conference December 4, 2003

Evaluation and Management of the Breast Mass. Gary Dunnington,, M.D. Department of Surgery Internal Medicine Ambulatory Conference December 4, 2003 Evaluation and Management of the Breast Mass Gary Dunnington,, M.D. Department of Surgery Internal Medicine Ambulatory Conference December 4, 2003 Common Presentations of Breast Disease Breast Mass Abnormal

More information

Learning Objectives. Breast Density, Risk Assessment and Supplemental Screening Options. Breast Density. What is Breast Density??

Learning Objectives. Breast Density, Risk Assessment and Supplemental Screening Options. Breast Density. What is Breast Density?? , Risk Assessment and Supplemental Screening Options ASCLS ND Convention May 2016 Christina Tello Skjerseth, MD Sanford Health Bismarck Radiology Learning Objectives Understand what breast density is and

More information

Name of Policy: Reconstructive versus Cosmetic Surgery

Name of Policy: Reconstructive versus Cosmetic Surgery Name of Policy: Reconstructive versus Cosmetic Surgery Policy #: 106 Latest Review Date: February 2010 Category: Administrative Policy Grade: Background/Definitions: As a general rule, benefits are payable

More information

CLINICAL NEGLIGENCE ARTICLE: THE DETECTION & TREATMENT OF BREAST CANCER & CLAIMS FOR LOSS OF LIFE EXPECTANCY IN CLINICAL NEGLIGENCE CASES

CLINICAL NEGLIGENCE ARTICLE: THE DETECTION & TREATMENT OF BREAST CANCER & CLAIMS FOR LOSS OF LIFE EXPECTANCY IN CLINICAL NEGLIGENCE CASES CLINICAL NEGLIGENCE ARTICLE: THE DETECTION & TREATMENT OF BREAST CANCER & CLAIMS FOR LOSS OF LIFE EXPECTANCY IN CLINICAL NEGLIGENCE CASES Reports relating to the detection and treatment of breast cancer

More information

Accelerated Partial Breast Irradiation (APBI) for Breast Cancer [Preauthorization Required]

Accelerated Partial Breast Irradiation (APBI) for Breast Cancer [Preauthorization Required] Accelerated Partial Breast Irradiation (APBI) for Breast Cancer [Preauthorization Required] Medical Policy: MP-SU-01-11 Original Effective Date: February 24, 2011 Reviewed: Revised: This policy applies

More information

Understanding Your Surgical Options For Breast Cancer

Understanding Your Surgical Options For Breast Cancer RADIATION THERAPY SYMPTOM MANAGEMENT CANCER INFORMATION Understanding Your Surgical Options For Breast Cancer In this booklet you will learn about: Role of surgery in breast cancer diagnosis and treatment

More information

Is it time for a new drug development paradigm?

Is it time for a new drug development paradigm? Is it time for a new drug development paradigm? Robert McDonough, M.D. Senior Director, Clinical Policy Research and Development 1 The Aetna Way Our Cause To make quality health care more affordable and

More information

Information Model Requirements of Post-Coordinated SNOMED CT Expressions for Structured Pathology Reports

Information Model Requirements of Post-Coordinated SNOMED CT Expressions for Structured Pathology Reports Information Model Requirements of Post-Coordinated SNOMED CT Expressions for Structured Pathology Reports W. Scott Campbell, Ph.D., MBA James R. Campbell, MD Acknowledgements Steven H. Hinrichs, MD Chairman

More information

Nicole Kounalakis, MD

Nicole Kounalakis, MD Breast Disease: Diagnosis and Management Nicole Kounalakis, MD Assistant Professor of Surgery Goal of Breast Evaluation The goal of breast evaluation is to classify findings as: normal physiologic variations

More information

Local control in ductal carcinoma in situ treated by excision alone: incremental benefit of larger margins

Local control in ductal carcinoma in situ treated by excision alone: incremental benefit of larger margins The American Journal of Surgery 190 (2005) 521 525 George Peter s Award Winner Local control in ductal carcinoma in situ treated by excision alone: incremental benefit of larger margins Heather R. MacDonald,

More information

Guide to Understanding Breast Cancer

Guide to Understanding Breast Cancer An estimated 220,000 women in the United States are diagnosed with breast cancer each year, and one in eight will be diagnosed during their lifetime. While breast cancer is a serious disease, most patients

More information

BRACHYTHERAPY FOR TREATMENT OF BREAST CANCER

BRACHYTHERAPY FOR TREATMENT OF BREAST CANCER BRACHYTHERAPY FOR TREATMENT OF BREAST CANCER Coverage for services, procedures, medical devices and drugs are dependent upon benefit eligibility as outlined in the member's specific benefit plan. This

More information

Modifier Usage Guide What Your Practice Needs to Know

Modifier Usage Guide What Your Practice Needs to Know BlueCross BlueShield of Mississippi Modifier Usage Guide What Your Practice Needs to Know Modifier 22 Usage Modifier 22 - Procedural Service The purpose of this modifier is to report services (surgical

More information

PSA Screening for Prostate Cancer Information for Care Providers

PSA Screening for Prostate Cancer Information for Care Providers All men should know they are having a PSA test and be informed of the implications prior to testing. This booklet was created to help primary care providers offer men information about the risks and benefits

More information

dedicated to curing BREAST CANCER

dedicated to curing BREAST CANCER dedicated to curing BREAST CANCER When you are diagnosed with breast cancer, you need a team of specialists who will share their knowledge of breast disease and the latest treatments available. At Cancer

More information

Corporate Medical Policy

Corporate Medical Policy Corporate Medical Policy Proteomics-based Testing Related to Ovarian Cancer File Name: Origination: Last CAP Review: Next CAP Review: Last Review: proteomics_based_testing_related_to_ovarian_cancer 7/2010

More information

Objectives. Mylene T. Truong, MD. Malignant Pleural Mesothelioma Background

Objectives. Mylene T. Truong, MD. Malignant Pleural Mesothelioma Background Imaging of Pleural Tumors Mylene T. Truong, MD Imaging of Pleural Tumours Mylene T. Truong, M. D. University of Texas M.D. Anderson Cancer Center, Houston, TX Objectives To review tumors involving the

More information

Helen Joseph Breast Care Clinic - Johannesburg, South Africa

Helen Joseph Breast Care Clinic - Johannesburg, South Africa - Johannesburg, South Africa General Information New breast cancer cases treated per year 360 Breast multidisciplinarity team members 12 Radiologists, surgeons, pathologists, medical oncologists, radiotherapists

More information

Inova. Breast Care Institute

Inova. Breast Care Institute Inova Breast Care Institute At the Inova Breast Care Institute, our commitment is to provide expert care for you, every step of the way. Our multidisciplinary team of more than 80 experts provides a full

More information

Wisconsin Cancer Data Bulletin Wisconsin Department of Health Services Division of Public Health Office of Health Informatics

Wisconsin Cancer Data Bulletin Wisconsin Department of Health Services Division of Public Health Office of Health Informatics Wisconsin Cancer Data Bulletin Wisconsin Department of Health Services Division of Public Health Office of Health Informatics In Situ Breast Cancer in Wisconsin INTRODUCTION This bulletin provides information

More information

Corporate Medical Policy

Corporate Medical Policy Corporate Medical Policy File Name: Origination: Last CAP Review: Next CAP Review: Last Review: microwave_tumor_ablation 12/2011 11/2015 11/2016 11/2015 Description of Procedure or Service Microwave ablation

More information

INTERDISCIPLINARY CONFERENCE. Florence/Firenze, Italy Nov 27-29, 2012 Centro Congressi al Duomo, Firenze BREAST SEMINAR SERIES

INTERDISCIPLINARY CONFERENCE. Florence/Firenze, Italy Nov 27-29, 2012 Centro Congressi al Duomo, Firenze BREAST SEMINAR SERIES Since breast cancer is not a systemic disease from inception, when the imagers find in situ and 1-14 mm invasive breast cancer, it is the surgeon, specialized in the treatment of breast diseases, who should

More information

CHAPTER 2. Neoplasms (C00-D49) March 2014. 2014 MVP Health Care, Inc.

CHAPTER 2. Neoplasms (C00-D49) March 2014. 2014 MVP Health Care, Inc. Neoplasms (C00-D49) March 2014 2014 MVP Health Care, Inc. CHAPTER SPECIFIC CATEGORY CODE BLOCKS C00-C14 Malignant neoplasms of lip, oral cavity and pharynx C15-C26 Malignant neoplasms of digestive organs

More information

RESEARCH EDUCATE ADVOCATE. Just Diagnosed with Melanoma Now What?

RESEARCH EDUCATE ADVOCATE. Just Diagnosed with Melanoma Now What? RESEARCH EDUCATE ADVOCATE Just Diagnosed with Melanoma Now What? INTRODUCTION If you are reading this, you have undergone a biopsy (either of a skin lesion or a lymph node) or have had other tests in which

More information

Pathologic Assessment Of The Breast And Axilla After Preoperative Therapy

Pathologic Assessment Of The Breast And Axilla After Preoperative Therapy Pathologic Assessment Of The Breast And Axilla After Preoperative Therapy W. Fraser Symmans, M.D. Associate Professor of Pathology UT M.D. Anderson Cancer Center Pathologic Complete Response (pcr) Proof

More information

Electronic health records to study population health: opportunities and challenges

Electronic health records to study population health: opportunities and challenges Electronic health records to study population health: opportunities and challenges Caroline A. Thompson, PhD, MPH Assistant Professor of Epidemiology San Diego State University Caroline.Thompson@mail.sdsu.edu

More information

Adjuvant Therapy for Breast Cancer: Questions and Answers

Adjuvant Therapy for Breast Cancer: Questions and Answers CANCER FACTS N a t i o n a l C a n c e r I n s t i t u t e N a t i o n a l I n s t i t u t e s o f H e a l t h D e p a r t m e n t o f H e a l t h a n d H u m a n S e r v i c e s Adjuvant Therapy for Breast

More information

Breast Cancer. Sometimes cells keep dividing and growing without normal controls, causing an abnormal growth called a tumor.

Breast Cancer. Sometimes cells keep dividing and growing without normal controls, causing an abnormal growth called a tumor. Breast Cancer Introduction Cancer of the breast is the most common form of cancer that affects women but is no longer the leading cause of cancer deaths. About 1 out of 8 women are diagnosed with breast

More information

PSA Testing 101. Stanley H. Weiss, MD. Professor, UMDNJ-New Jersey Medical School. Director & PI, Essex County Cancer Coalition. weiss@umdnj.

PSA Testing 101. Stanley H. Weiss, MD. Professor, UMDNJ-New Jersey Medical School. Director & PI, Essex County Cancer Coalition. weiss@umdnj. PSA Testing 101 Stanley H. Weiss, MD Professor, UMDNJ-New Jersey Medical School Director & PI, Essex County Cancer Coalition weiss@umdnj.edu September 23, 2010 Screening: 3 tests for PCa A good screening

More information

Goals and Objectives: Breast Cancer Service Department of Radiation Oncology

Goals and Objectives: Breast Cancer Service Department of Radiation Oncology Goals and Objectives: Breast Cancer Service Department of Radiation Oncology The breast cancer service provides training in the diagnosis, management, treatment, and follow-up of breast malignancies, including

More information

Early-stage Breast Cancer Treatment: A Patient and Doctor Dialogue

Early-stage Breast Cancer Treatment: A Patient and Doctor Dialogue page 1 Early-stage Breast Cancer Treatment: A Patient and Doctor Dialogue Q: What is breast cancer, and what type do I have? A: Cancer is a disease in which cells become abnormal and form more cells in

More information

Management of Postmenopausal Women with T1 ER+ Tumors: Options and Tradeoffs. Case Study. Surgery. Lumpectomy and Radiation

Management of Postmenopausal Women with T1 ER+ Tumors: Options and Tradeoffs. Case Study. Surgery. Lumpectomy and Radiation Management of Postmenopausal Women with T1 ER+ Tumors: Options and Tradeoffs Michael Alvarado, MD Associate Professor of Surgery University of California San Francisco Case Study 59 yo woman with new palpable

More information

Low-dose CT Imaging. Edgar Fearnow, M.D. Section Chief, Computed Tomography, Lancaster General Hospital

Low-dose CT Imaging. Edgar Fearnow, M.D. Section Chief, Computed Tomography, Lancaster General Hospital Lung Cancer Screening with Low-dose CT Imaging Edgar Fearnow, M.D. Section Chief, Computed Tomography, Lancaster General Hospital Despite recent declines in the incidence of lung cancer related to the

More information

Surgery Choices. National Cancer Institute. For Women with DCIS or Breast Cancer. National Institutes of Health

Surgery Choices. National Cancer Institute. For Women with DCIS or Breast Cancer. National Institutes of Health National Cancer Institute Surgery Choices For Women with DCIS or Breast Cancer U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health The National Cancer Institute is grateful for our

More information

NEW HYBRID IMAGING TECHNOLOGY MAY HAVE BIG POTENTIAL FOR IMPROVING DIAGNOSIS OF PROSTATE CANCER

NEW HYBRID IMAGING TECHNOLOGY MAY HAVE BIG POTENTIAL FOR IMPROVING DIAGNOSIS OF PROSTATE CANCER Media Release April 7, 2009 For Immediate Release NEW HYBRID IMAGING TECHNOLOGY MAY HAVE BIG POTENTIAL FOR IMPROVING DIAGNOSIS OF PROSTATE CANCER London, Ontario Improved hybrid imaging techniques developed

More information

A Practical Guide to Advances in Staging and Treatment of NSCLC

A Practical Guide to Advances in Staging and Treatment of NSCLC A Practical Guide to Advances in Staging and Treatment of NSCLC Robert J. Korst, M.D. Director, Thoracic Surgery Medical Director, The Blumenthal Cancer Center The Valley Hospital Objectives Revised staging

More information

Chart Audits: The how s and why s By: Victoria Kaprielian, MD Barbara Gregory, MPH Dev Sangvai, MD

Chart Audits: The how s and why s By: Victoria Kaprielian, MD Barbara Gregory, MPH Dev Sangvai, MD Chart Audits: The how s and why s By: Victoria Kaprielian, MD Barbara Gregory, MPH Dev Sangvai, MD By Victoria Kaprielian, MD Associate Clinical Professor Barbara Gregory, MPH Quality Analyst Dev Sangvai,

More information

PET/CT for Melanoma. Sarajevo (Bosnia & Hercegovina) Wednesday, June :40 10:20

PET/CT for Melanoma. Sarajevo (Bosnia & Hercegovina) Wednesday, June :40 10:20 Sarajevo (Bosnia & Hercegovina) Wednesday, June 18 2014 09:40 10:20 PET/CT for Melanoma The Trundholm Sun Chariot, anterior view app 1350 BC The National Museum of Denmark, Copenhagen 54 x 35 x 29 cm (width,

More information

Accelerated Partial Breast Irradiation (APBI) for Breast Cancer [Pre-authorization Required]

Accelerated Partial Breast Irradiation (APBI) for Breast Cancer [Pre-authorization Required] Accelerated Partial Breast Irradiation (APBI) for Breast Cancer [Pre-authorization Required] Medical Policy: MP-SU-01-11 Original Effective Date: February 24, 2011 Reviewed: February 24, 2012 Revised:

More information

When it comes to treating breast cancer, doing less does more October is Breast Cancer Awareness Month

When it comes to treating breast cancer, doing less does more October is Breast Cancer Awareness Month For Immediate Release Oct. 8, 2012 When it comes to treating breast cancer, doing less does more October is Breast Cancer Awareness Month SEATTLE Oncologists and researchers are discovering that when it

More information

Clinical Trials and Screening: What You Need to Know

Clinical Trials and Screening: What You Need to Know Scan for mobile link. Clinical Trials and Screening: What You Need to Know What is a Clinical Trial? At A Glance A clinical trial is a research study that tests how well new medical techniques work in

More information

How TARGIT Intra-operative Radiotherapy can help Older Patients with Breast cancer

How TARGIT Intra-operative Radiotherapy can help Older Patients with Breast cancer How TARGIT Intra-operative Radiotherapy can help Older Patients with Breast cancer Jeffrey S Tobias, Jayant S Vaidya, Frederik Wenz and Michael Baum, University College Hospital, London, UK - on behalf

More information

National Cancer Institute

National Cancer Institute National Cancer Institute Taking Part in Cancer Treatment Research Studies U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Taking Part in Cancer Treatment Research Studies If

More information

BREAST CANCER PATHOLOGY

BREAST CANCER PATHOLOGY BREAST CANCER PATHOLOGY FACT SHEET Version 4, Aug 2013 This fact sheet was produced by Breast Cancer Network Australia with input from The Royal College of Pathologists of Australasia I m a nurse and know

More information

Participant Information Sheet/Consent Form. Norfolk & Norwich University Hospital NHS Foundation Trust. Marc Moncrieff

Participant Information Sheet/Consent Form. Norfolk & Norwich University Hospital NHS Foundation Trust. Marc Moncrieff Participant Information Sheet/Consent Form Norfolk & Norwich University Hospital NHS Foundation Trust Short Title The Melanoma Margins Trial (MelMarT) Title A Phase III, Multi-centre Randomised Control

More information

BAISHIDENG PUBLISHING GROUP INC

BAISHIDENG PUBLISHING GROUP INC Reviewer s code: 01714224 Reviewer s country: Italy Date reviewed: 2015-01-30 20:36 [ Y] Grade A: Priority publishing [ ] Accept [ ] Grade C: Good [ Y] Grade D: Fair language [ Y] Major revision The article

More information

Ductal carcinoma in situ (DCIS)

Ductal carcinoma in situ (DCIS) DIAGNOSIS: DCIS Ductal carcinoma in situ (DCIS) This factsheet gives information on an early form of breast cancer called ductal carcinoma in situ (DCIS). It explains what it is, how your breast is made

More information

Malignant Lesions. 1. Distribution of Tumor. 1.1. Unifocal Carcinoma

Malignant Lesions. 1. Distribution of Tumor. 1.1. Unifocal Carcinoma 23 Malignant Lesions 1. Distribution of Tumor 1.1. Unifocal Carcinoma Figure 23.1. A 40-year-old woman presented with a palpable mass in the periareolar region. Ultrasound core biopsy yielded invasive

More information

CLINICAL TRIALS SHOULD YOU PARTICIPATE? by Gwen L. Nichols, MD

CLINICAL TRIALS SHOULD YOU PARTICIPATE? by Gwen L. Nichols, MD CLINICAL TRIALS SHOULD YOU PARTICIPATE? by Gwen L. Nichols, MD Gwen L. Nichols, M.D., is currently the Oncology Site Head of the Roche Translational Clinical Research Center at Hoffman- LaRoche. In this

More information

Breast. Patient information. cancer clinical pathway

Breast. Patient information. cancer clinical pathway Breast Patient information cancer clinical pathway This leaflet was written to properly inform people following breast cancer treatment plan. It doesn t replace the dialogue with healthcare staff; it rather

More information

Treatment of Metastatic Non-Small Cell Lung Cancer: A Systematic Review of Comparative Effectiveness and Cost Effectiveness

Treatment of Metastatic Non-Small Cell Lung Cancer: A Systematic Review of Comparative Effectiveness and Cost Effectiveness Treatment of Metastatic Non-Small Cell Lung Cancer: A Systematic Review of Comparative Effectiveness and Cost Effectiveness Investigators: Paul G. Shekelle, MD, PhD, Director Alicia R. Maher, MD Clinical

More information

PRODYNOV. Targeted Photodynamic Therapy of Ovarian Peritoneal Carcinomatosis ONCO-THAI. Image Assisted Laser Therapy for Oncology

PRODYNOV. Targeted Photodynamic Therapy of Ovarian Peritoneal Carcinomatosis ONCO-THAI. Image Assisted Laser Therapy for Oncology PRODYNOV Targeted Photodynamic Therapy of Ovarian Peritoneal Carcinomatosis ONCO-THAI Image Assisted Laser Therapy for Oncology Inserm ONCO-THAI «Image Assisted Laser Therapy for Oncology» Inserm ONCO-THAI

More information

Breast Ultrasound: Benign vs. Malignant Lesions

Breast Ultrasound: Benign vs. Malignant Lesions October 25-November 19, 2004 Breast Ultrasound: Benign vs. Malignant Lesions Jill Steinkeler,, Tufts University School of Medicine IV Breast Anatomy Case Presentation-Patient 1 62 year old woman with a

More information

TAKING PART IN CANCER TREATMENT RESEARCH STUDIES

TAKING PART IN CANCER TREATMENT RESEARCH STUDIES For more infomation about Cancer Clinical Trials at Upstate Cancer Center please call Upstate Connect 1.800.464.8668 TAKING PART IN CANCER TREATMENT RESEARCH STUDIES Information provided by: National Cancer

More information

Introduction Breast cancer is cancer that starts in the cells of the breast. Breast cancer happens mainly in women. But men can get it too.

Introduction Breast cancer is cancer that starts in the cells of the breast. Breast cancer happens mainly in women. But men can get it too. Male Breast Cancer Introduction Breast cancer is cancer that starts in the cells of the breast. Breast cancer happens mainly in women. But men can get it too. Many people do not know that men can get breast

More information

A Checklist for Patients with Breast Cancer

A Checklist for Patients with Breast Cancer A Checklist for Patients with Breast Cancer Questions to Ask the Doctor 1 and Quick Help Resources 1 Adapted from: American Cancer Society. Detailed Guide: Breast Cancer - What Should You Ask Your Doctor

More information

Preservation and Incorporation of Valuable Endoscopic Innovations (PIVI)

Preservation and Incorporation of Valuable Endoscopic Innovations (PIVI) Preservation and Incorporation of Valuable Endoscopic Innovations (PIVI) The American Society for Gastrointestinal Endoscopy PIVI on Endoscopic Bariatric Procedures (short form) Please see related White

More information

Breast Imaging Made Brief and Simple. Jane Clayton MD Associate Professor Department of Radiology LSUHSC New Orleans, LA

Breast Imaging Made Brief and Simple. Jane Clayton MD Associate Professor Department of Radiology LSUHSC New Orleans, LA Breast Imaging Made Brief and Simple Jane Clayton MD Associate Professor Department of Radiology LSUHSC New Orleans, LA What women are referred for breast imaging? Two groups of women are referred for

More information

Sentinel Lymph Node Biopsy: An Information Guide for Patients

Sentinel Lymph Node Biopsy: An Information Guide for Patients Sentinel Lymph Node Biopsy: An Information Guide for Patients Disclaimer This is general information developed by The Ottawa Hospital. It is not intended to replace the advice of a qualified healthcare

More information

D. FREQUENTLY ASKED QUESTIONS

D. FREQUENTLY ASKED QUESTIONS ACR BI-RADS ATLAS D. FREQUENTLY ASKED QUESTIONS 1. Under MQSA, is it necessary to include a numeric assessment code (i.e., 0, 1, 2, 3, 4, 5, or 6) in addition to the assessment category in all mammography

More information

ALCHEMIST (Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trials)

ALCHEMIST (Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trials) ALCHEMIST (Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trials) 3 Integrated Trials Testing Targeted Therapy in Early Stage Lung Cancer Part of NCI s Precision Medicine Effort in

More information

Accelerated Partial Breast Irradiation (APBI) for Breast Cancer

Accelerated Partial Breast Irradiation (APBI) for Breast Cancer Accelerated Partial Breast Irradiation (APBI) for Breast Cancer [For the list of services and procedures that need preauthorization, please refer to www.mcs.pr Go to Comunicados a Proveedores, and click

More information

Coverage Analysis: The Cornerstone of Clinical Research Billing Presented by: Mary L. Veazie, CPA, MBA, CHC, CHRC Executive Director, Clinical

Coverage Analysis: The Cornerstone of Clinical Research Billing Presented by: Mary L. Veazie, CPA, MBA, CHC, CHRC Executive Director, Clinical Coverage Analysis: The Cornerstone of Clinical Research Billing Presented by: Mary L. Veazie, CPA, MBA, CHC, CHRC Executive Director, Clinical Research Finance The University of Texas MD Anderson Cancer

More information

Guideline for the Imaging of Patients Presenting with Breast Symptoms incorporating the guideline for the use of MRI in breast cancer

Guideline for the Imaging of Patients Presenting with Breast Symptoms incorporating the guideline for the use of MRI in breast cancer Guideline for the Imaging of Patients Presenting with Breast Symptoms incorporating the guideline for the use of MRI in breast cancer Version History Version Date Summary of Change/Process 0.1 09.01.11

More information

Guidance for Industry FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products

Guidance for Industry FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products Guidance for Industry FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation

More information

FACTS about. MENTOR MemoryGel. Silicone Gel Filled Breast Implants

FACTS about. MENTOR MemoryGel. Silicone Gel Filled Breast Implants FACTS about MENTOR MemoryGel Silicone Gel Filled Breast Implants Are you considering breast implant surgery but not certain which type of implant to choose? You re not alone. Science-based information

More information

Tubular breast cancer

Tubular breast cancer Tubular breast cancer This booklet is for people who would like more information about tubular breast cancer. It describes what tubular breast cancer is, its symptoms, how a diagnosis is made and the possible

More information

Azienda Ospedale Annunziata Cosenza - Cosenza, Italy

Azienda Ospedale Annunziata Cosenza - Cosenza, Italy - Cosenza, Italy General Information New breast cancer cases treated per year 180 Breast multidisciplinarity team members 9 Radiologists, surgeons, pathologists, medical oncologists, radiotherapists and

More information

KIDNEY FUNCTION RELATION TO SIZE OF THE TUMOR IN RENAL CELL CANCINOMA

KIDNEY FUNCTION RELATION TO SIZE OF THE TUMOR IN RENAL CELL CANCINOMA KIDNEY FUNCTION RELATION TO SIZE OF THE TUMOR IN RENAL CELL CANCINOMA O.E. Stakhvoskyi, E.O. Stakhovsky, Y.V. Vitruk, O.A. Voylenko, P.S. Vukalovich, V.A. Kotov, O.M. Gavriluk National Canсer Institute,

More information

VI. FREQUENTLY ASKED QUESTIONS CONCERNING BREAST IMAGING AUDITS

VI. FREQUENTLY ASKED QUESTIONS CONCERNING BREAST IMAGING AUDITS ACR BI-RADS ATLAS VI. FREQUENTLY ASKED QUESTIONS CONCERNING BREAST IMAGING AUDITS American College of Radiology 55 ACR BI-RADS ATLAS A. All Breast Imaging Modalities 1. According to the BI-RADS Atlas,

More information

Liver Cancer And Tumours

Liver Cancer And Tumours Liver Cancer And Tumours What causes liver cancer? Many factors may play a role in the development of cancer. Because the liver filters blood from all parts of the body, cancer cells from elsewhere can

More information

The Captivator II Snares are the first line of stiff and rounded snares available in multiple sizes with both a hot and cold snaring indication.

The Captivator II Snares are the first line of stiff and rounded snares available in multiple sizes with both a hot and cold snaring indication. Captivator II Single-Use Snares The Captivator II Snares are the first line of stiff and rounded snares available in multiple sizes with both a hot and cold snaring indication. The Captivator II Snare

More information

Patient Guide. Brachytherapy: The precise answer for tackling breast cancer. Because life is for living

Patient Guide. Brachytherapy: The precise answer for tackling breast cancer. Because life is for living Patient Guide Brachytherapy: The precise answer for tackling breast cancer Because life is for living This booklet is designed to provide information that helps women who have been diagnosed with early

More information

Integumentary System Individual Exercises

Integumentary System Individual Exercises Integumentary System Individual Exercises 1. A physician performs an incision and drainage of a subcutaneous abscess in his office for a particularly uncooperative established patient. How should this

More information

Clinical Trials: Questions and Answers

Clinical Trials: Questions and Answers Clinical Trials: Questions and Answers Key Points Clinical trials are research studies that test how well new medical approaches work in people (see Question 1). Every clinical trial has a protocol, which

More information

Breast screening results and assesment

Breast screening results and assesment Breast screening results and assesment This information is an extract from the booklet, Understanding breast screening. You may find the full booklet helpful. We can send you a copy free see page 9. Contents

More information

MAMMOGRAPHY GOALS AND OBJECTIVES

MAMMOGRAPHY GOALS AND OBJECTIVES MAMMOGRAPHY GOALS AND OBJECTIVES GOALS: After completion of the mammography rotations, the resident will be able to: 1. Demonstrate learning of the knowledge-based objectives-(practice Base Learning) 2.

More information

Recommendations for cross-sectional imaging in cancer management, Second edition

Recommendations for cross-sectional imaging in cancer management, Second edition www.rcr.ac.uk Recommendations for cross-sectional imaging in cancer management, Second edition Breast cancer Faculty of Clinical Radiology www.rcr.ac.uk Contents Breast cancer 2 Clinical background 2 Who

More information

Report series: General cancer information

Report series: General cancer information Fighting cancer with information Report series: General cancer information Eastern Cancer Registration and Information Centre ECRIC report series: General cancer information Cancer is a general term for

More information