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

Size: px
Start display at page:

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

Transcription

1 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 of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Food and Drug Administration

2 Outline of FDA Presentations Introduction and Background Clinical Study Design: Weijie Chen, PhD Statistical Results: Jingjing Ye, PhD Clinical Significance: Gary Levine, MD, MSE Panel Discussion 2

3 FDA Review Team Robert Ochs, PhD Gary Levine, MD, MSE Jingjing Ye, PhD Weijie Chen, PhD Frank Samuelson, PhD Helen Barr, MD Lead Reviewer Division of Radiological Health Medical Officer Division of Radiological Health Statistician Division of Biostatistics Scientist Division of Imaging and Applied Mathematics Scientist Division of Imaging and Applied Mathematics Director Division of Mammography Quality Standards 3

4 Selenia Dimensions 3D System The device is currently approved for breast cancer screening and diagnosis (PMA-number: P080003) The screening exam can consist of full field digital mammography (FFDM) alone or the combination of FFDM with digital breast tomosynthesis (DBT) 4

5 Premarket Approval (PMA) Supplement Selenia Dimensions 3D System with C-View Software Module Ability to create synthesized 2D views from the 3D data No other significant hardware or software changes Expanded Indications for Use 3D plus synthesized 2D images for screening 3D S = 3D plus synthesized 2D 5

6 Proposed Indications for Use The Hologic Selenia Dimensions system generates digital mammographic images that can be used for screening and diagnosis of breast cancer. The Selenia Dimensions (2D or 3D) system is intended for use in the same clinical applications as a 2D mammography system for screening mammograms. Specifically, the Selenia Dimensions system can be used to acquire 2D digital mammograms and 3D mammograms. Each view in a screening examination will consist of: a 2D image set, or a 2D and 3D image set, or a 3D image set in combination with a synthesized 2D image set The Selenia Dimensions system may also be used for additional diagnostic workup of the breast. 6

7 C-View Software Module The C-View software generates synthesized 2D images from the 3D tomosynthesis data The synthesized 2D views are similar to a maximum intensity projection of the 3D data Images will include a C-View mark to alert users that they are not FFDM images (not shown in the example) RMLO 2D FFDM Synthesized 2D RMLO 7

8 Configuration The default contrast of the synthesized 2D images can be set to low, medium, or high (window/level settings allow further adjustment by user) Medium contrast was used for the reader study Low Medium High 8

9 Configuration The appearance of the skin line on the synthesized 2D images can be set as less prominent or more prominent The more prominent skin line was used for the reader study Less Prominent More Prominent 9

10 FDA Review of PMA Supplement Hologic s PMA supplement was reviewed in the context of the proposed indications for use, and the potential impact on the clinical practice of mammography 10

11 Panel Discussion The panel will be asked to consider: Potential impact on performing and interpreting mammography when using 3D S and not acquiring FFDM Study bias Study exclusions Safety Effectiveness Benefit and risk 11

12 Next Speaker The next speaker is Dr. Weijie Chen 12

13 Radiology Advisory Panel Meeting Hologic Selenia Dimensions 3D System with C-View Software Module Clinical Study Design Weijie Chen, PhD Division of Imaging and Applied Mathematics Office of Science and Engineering Laboratories Center for Devices and Radiological Health Food and Drug Administration

14 Outline General considerations Controlled multi-reader multi-case (MRMC) study ROC methodology Pivotal study Objective to Panel Case selection Readers Image interpretation Mainly related Questions 2 & 3 14

15 Radiologist Performance in Breast Cancer Screening Is Selenia Dimensions 3D S (3D digital breast tomosynthesis (DBT) in combination with synthetic 2D images) non-inferior to the standard of care 2D FFDM for breast cancer screening? Controlled multi-reader multi-case (MRMC) study ROC methodology 15

16 Prospective vs. Controlled Retrospective Clinical Studies Prospective Clinical Study Reader decisions affect patient management Multiple readers usually do not read the same case No Enrichment Reading conditions may be difficult to control Real world, multi-institutional Can lead to absolute scale performance estimates e.g., cancers per 1000 women Retrospective Clinical Study Reader decisions do not affect patient management Multiple readers read the same case Enrichment Esp. when prevalence is low Well-controlled reading conditions Some components in clinical reading may be absent Compare two modalities e.g., 3D S vs. FFDM 16

17 Controlled Retrospective Studies Do not provide absolute measures of performance Possible differences in case mix, reader training and experience, availability of prior images, patient history, reader mindset Provide meaningful and least-burdensome comparison of imaging modalities Have been used to bring to market several imaging devices Full-field digital mammography (FFDM) Compared to screen-film mammography Digital breast tomosynthesis (DBT) Combined with FFDM compared to FFDM alone Computer-aided detection (CAD) Compared to reader alone 17

18 Receiver Operating Characteristics Clinical decisions Often binary: e.g. call the patient back vs. do not call the patient back ROC methodology Multiple levels of confidence in disease presence Independent of decision threshold, which varies with user experience and training ROC analysis and area under the ROC curve (AUC) are consistent indicators of diagnostic information given to a physician Can be especially useful when one modality has higher sensitivity but lower specificity than the other 18

19 AUC vs (Sensitivity, Specificity) Example (presented in the panel meeting for the original Hologic PMA P080003, 09/24/2010): FFDM vs FFDM+DBT (original Hologic PMA) Table of changes in diagnostic measures Study ΔSens ΔSpec ΔAUC 1 st Study ( ) ( ) (4-11%) 2 nd Study (4-10%) 3 rd Study ( )

20 Study Objective: Rationale ACR phantom dose per view Mode Hologic FFDM Hologic 3D S (DBT+Synthetic 2D) Hologic FFDM+DBT Average dose of FFDM* Average dose of S/F* Average dose of CR* MQSA Limit Dose for Single View 1.2 mgy 1.45 mgy 2.65 mgy 1.43 mgy 1.77 mgy 1.90 mgy 3.0 mgy * Collected from medical physicists dose measurements available at the time of MQSA inspections Jan Sept

21 Study Objective: Primary Compare radiologist performance in detecting breast cancer in terms of the area under the ROC Curve (AUC) 2D FFDM (CC & MLO views) -- FFDM vs. 3D DBT (CC & MLO views) plus synthetic 2D views (CC & MLO views) -- 3D S AUC of 3D S is non-inferior to that of FFDM with a non-inferiority margin of

22 Study Objectives: Secondary AUC for subjects with dense breasts using 3Ds is non-inferior to that of FFDM (noninferiority margin: 0.05) The non-cancer recall rate for 3D S is noninferior to that of FFDM (non-inferiority margin: 5%) 22

23 Case Selection: Inclusion/Exclusion Criteria Inclusion Criteria Female No contraindication for routine bilateral mammography Exclusion Criteria Subjects who presented with any contraindications to mammographic screening Previous surgical (excisional) biopsy Previous breast cancer Placement of an internal breast marker Breast implants or breast reduction surgery Subjects who were unable to understand or execute written informed consent Breasts too large to be imaged on a 24 cm by 29 cm detector with a single exposure 23

24 Case Selection: Image Acquisition 3521 subjects from 22 prequalified clinical centers 2985 of the subjects eligible 19.8% (590/2985) of eligible cases were excluded for image Q/C 300 FFDM 171 DBT 137 positioning (both FFDM and DBT) The 302 cases used for the reader study were randomly selected using stratified sampling 3521 subjects imaged 3285 Subjects 2985 eligible 2299 eligible 302 selected 200 at site 590 Q/C 236 Training 100 incorrect tech tables 96 protocol/pilot 1997 not in study Red box represents cases excluded 24

25 Case Selection: Selection Categories and Truthing Case selection categories Negative screening cases negative by FFDM reader and FFDM+DBT reader at acquisition site Recalled screening cases recalled by FFDM reader or FFDM+DBT reader at acquisition site, but not biopsied Benign biopsy cases - pathology proven benign cases Cancer cases pathology proven malignant cases Truthing: Pathology and one-year follow up 9/302 lost to follow up 1/76 benign lesions found to be cancer by follow-up 25

26 Case Selection: Case Mix and Enrichment Case Type Current study Original PMA Cancer 77 (25%) 51 (16%) Benign 75 (25%) 47 (15%) Recall 24 (8%) 138 (45%) Negatives 126 (42%) 74 (24%) Total The proportion of recall cases was chosen to reduce potential bias in favor of 3D S on noncancer recall rate. 26

27 Case Selection: Case Mix and Enrichment Case Type Current study Original PMA Cancer 77 (25%) 51 (16%) Benign 75 (25%) 47 (15%) Recall 24 (8%) 138 (45%) Negatives 126 (42%) 74 (24%) Total The proportion of cancer cases was increased to gain statistical power. 27

28 Case Selection: Case Mix and Enrichment Case Type Current study Original PMA Cancer 77 (25%) 51 (16%) Benign 75 (25%) 47 (15%) Recall 24 (8%) 138 (45%) Negatives 126 (42%) 74 (24%) Total In the non-cancer categories, the proportion of benign+recall cases decreased (from 60% to 33%) while the proportion of negative cases increased (from 24% to 42%). Differentiating cancer from non-cancers may be easier for both FFDM and 3D S. May bias in favor of showing non-inferiority between FFDM and 3D S. 28

29 Case Selection: Distribution by Breast Density BI-RADS Breast Density Category Cases (n=302) 1 37 (12.3%) (38.7%) (39.1%) 4 30 (9.9%) Fatty: 51% Dense: 49% 29

30 Case Selection: Calcifications/non-calcs Case Type Calcification Non-Calcs Total Cancer Recall Benign Negative Total Cases presenting with only calcifications were considered the calcification group. Cases with mass only or both mass and calcifications were considered with the non-calcification group. 30

31 Radiologists/Readers Fifteen radiologists representing a range of clinical experience participated in the reader study Board certified, MQSA qualified, trained in and familiar with the interpretation of digital mammography, and users of the Hologic SecurView workstation. Reader training Two full days of training on the reading of 3D tomosynthesis with synthesized 2D images prior to the start of the reader study. FDA requested that the statistical analysis be performed with all 15 readers 31

32 Image Interpretation: Study Design Fully paired acquisition Cross-over reading to mitigate readingorder effect Session 1 (One Month) Session 2 FFDM 3D S 3D S FFDM First half of the cases Second half First half of the cases Second half 32

33 Image Interpretation: Scoring The following information was collected for each marked lesion: Lesion location Probability of Malignancy (POM) score of 0 to 100 Forced BI-RADS score of 1, 2, 3, 4a, 4b, 4c, or 5 The following information was collected for cases with no marked lesions: POM score of 0 to 100 BI-RADS score of 1 or 2 33

34 Summary Controlled retrospective Multi-Reader Multi-Case (MRMC) study on an enriched patient dataset 15 Board certified and MQSA qualified radiologists 302 cases (77 cancer, 225 non-cancer) Case dataset is enriched with different proportions of cancers/non-cancers than the general screening population. Two-session cross-over reading separated by a one-month memory wash-out period Primary Objective Show AUC of 3D S is non-inferior to that of FFDM with a non-inferiority margin of

35 Summary Lost patients could impact performance About 20% of eligible cases were excluded due to image quality control issues. The protocol did not allow for repeat imaging on these cases. Nine of the 302 study cases were lost to follow-up. The higher relative proportions of negative screening cases could favor the non-inferiority hypothesis The study excluded: Previous surgical (excisional) biopsy Placement of an internal breast marker Breast implants or breast reduction surgery Breasts too large to be imaged with a single exposure 35

36 Next Speaker The next speaker is Dr. Jingjing Ye 36

37 Radiology Advisory Panel Meeting Hologic Selenia Dimensions 3D System with C-View Software Module FDA Statistical Review Jingjing Ye, PhD Mathematical Statistician Division of Biostatistics Center for Devices and Radiological Health

38 Overview Reader Study Results Primary endpoint (AUC) Secondary endpoints (Dense breast AUC, noncancer recall rate) Additional endpoints (sensitivity/specificity, subset AUC, cancer recall rate) Additional Robustness Analyses Discussion on Case Distribution Summary 38

39 Study Samples Completer In Study Not In Study Total Negative Recall Benign Cancer Total Present the completer analyses results for 293 patients 9 lost-to-follow-up subjects will be addressed in Additional Robustness Analyses 39

40 Study Endpoints Primary endpoint AUC: 3D S is non-inferior to 2D (Non-inferiority margin 0.05) Secondary endpoints: Dense breast AUC: 3D S is non-inferior to 2D (noninferiority margin 0.05) Non-cancer recall rate: 3D S is non-inferior to 2D (noninferiority margin 5%) Additional endpoints: Calcification and non-calcification AUC Sensitivity and specificity Fatty breast AUC Cancer recall rate Descriptive Statistics 40

41 Primary Endpoint-AUC Difference (3D S -2D FFDM) 41 41

42 Primary Analysis-AUC (Reader Averaged), 77 Cancers and 216 Non-cancers Method 2D FFDM 3D S Difference (95% CI lower bound) P-value+ (Non- Inferiority) Nonparametric (0.011) < Parametric (0.015) < DBM* Method used for primary analysis (FDA calculation) Non-inferiority margin is met +One-sided p-value *Dorfman, Berbaum, Metz, 1992 Invest Radiol 27(9):

43 Secondary Endpoint-Dense Breast (AUC difference: 3D S -2D) 43 43

44 Dense Breast AUC (Reader Averaged), Method 37 Cancers and 106 Non-cancers (Secondary Endpoint) 2D FFDM 3D S Difference (95% CI lower bound) & P-value+ (Non- Inferiority) Nonparametric (0.005) Parametric (0.007) < DBM* Method used in secondary analysis (FDA calculation) Non-inferiority margin is met & No multiplicity adjustment + One-sided p-value *Dorfman, Berbaum, Metz, 1992 Invest Radiol 27(9):

45 Non-cancer Recall Rate (Reader Averaged) (Secondary Endpoint) Method N 2D FFDM 3Ds Difference (3Ds-2D) 95% CI upper limit+ Non-cancer recall rate % 32.3% -14% -11.3% Random reader and random case bootstrap used (FDA calculation) Non-inferiority margin met +No multiplicity adjustment 45

46 Sensitivity, Specificity (Reader Averaged) (Additional Endpoint) Metric N 2D FFDM 3D S Difference Sensitivity % 86.8% 0.6% Specificity % 74.8% 10% BIRADS cut-off=4 BIRADS 1, 2, 3 test negative BIRADS 4, 5 test positive FDA calculation 46

47 Change in Sensitivity, Specificity by Reader 47

48 Calcification and Non-Calcification Calcification Non-Calcification Total Cancer Benign Recall Negative Total

49 Calcification and Non-Calcification (Reader Averaged) (Additional Endpoint) Calcification+ 2D FFDM 3D S Difference AUC Non-Calcification# 2D FFDM 3D S Difference AUC DBM Method used (Nonparametric AUC, FDA calculation) +Calcification: 24 cancers, 32 Non-cancers #Non-calcification: 53 cancers, 184 non-cancers 49

50 Fatty Breast (Reader Averaged) (Additional Endpoint) Fatty 2D FFDM 3Ds Difference AUC DBM Method used (Nonparametric AUC, FDA calculation) 40 cancers and 114 non-cancers 50

51 Cancer Recall Rate (Reader Averaged) (Additional Endpoint) Method 2D FFDM 3Ds Difference Recall rate # 88.7% 89.4% 0.7% Bootstrap for random reader and random cases (FDA calculation) # Not lesion-specific 51

52 Positive and Negative Likelihood Ratio (PLR and NLR) (Reader Averaged) Metric 2D FFDM 3D S Difference (95%CI)* PLR (0.72, 2.03) NLR (-0.084, 0.016) PLR : greater PPV with 3Ds (statistically significant) NLR : greater NPV with 3Ds (not statistically significant) Results do not depend on prevalence *Bootstrap CI, Unadjusted confidence interval *Biggerstaff, Stat medicine, 2000, 19, 649:663 52

53 Robustness Analysis 9 subjects lost-to-follow-up (unconfirmed noncancers) 8 in negative 1 in Benign Analyses scenarios Scenario 1: impute all as non-cancers Scenario 2: impute all as cancers Worst-case: impute k of 9 cases with highest POM in 3Ds as non-cancers, and remaining 9-k as cancers, k=1,,8 53

54 Robustness Analysis Results Data AUC Difference (95% lower bound) Dense Breast AUC Difference (95% lower bound) DBM Method used (Nonparametric AUC) Results robust to unconfirmed non-cancers * 9 lost-to-follow-up subjects as non-cancers + 9 lost-to-follow-up subjects as cancers Non-cancer Recall Rate Difference (95% upper bound) Completer (0.011) (0.005) -14% (-11.3%) Scenario 1* (0.01) (0.004) -13.9% (-11.4%) Scenario (0.01) (0.007) -14% (-11.2%) Worst-case (k=3) 0.031(0.007) ( ) -13.8% (-11.2%) 54

55 Missing Data - Exclusion Q/C Problem 21%(524/2536) non-cancers were excluded for Q/C 19% (66/353) cancers were excluded for Q/C Robust analyses done to examine the impact of Q/C exclusion Imputation Analyses Missing At Random Non-ignorable Missing Results of Primary Endpoint Met Mixed 55

56 Discussion on Case Distribution The current enrichment of samples may favor non-inferiority design Reweight case distributions according to previous PMA 25% cancers -> 16% Cancers 25% Benign -> 15% Benign 8% Recall -> 45% Recall 42% Negative -> 24% Negative 56

57 Primary Endpoint AUC Data 2D FFDM 3D S AUC Difference (95% CI lower bound) Scenario 1* (0.841, 0.878) (0.880, 0.911) (0.021) Reweighting (0.817, 0.858) (0.860, 0.894) (0.024) Bootstrap for random reader and random cases (FDA calculation) * 9 lost-to-follow-up subjects as non-cancers (25% Cancers, 25% Benign, 8% Recall and 42% Negative) + Reweighting according to P proportions (16% Cancers, 15% Benign, 45% Recall and 24% Negative) 57

58 Summary of Statistical Analysis Results For completers (excluding 9 lost to follow-up), the prespecified non-inferiority margins were met for the primary analysis of AUC difference (margin 0.05), the secondary analysis of dense breast AUC difference (margin 0.05), and the secondary analysis of non-cancer recall rate (margin 5%) Classifications favored device use: Non-cancer recall rate decreased by 14% (Secondary endpoint) Cancer recall rate increased by 0.7% (Additional endpoint) Likelihood ratios indicate increases in PPV, NPV 58

59 Summary of Statistical Analysis Results Study conclusions on AUC non-inferiority appeared to be Robust to 9 unconfirmed non-cancers Robust to Q/C exclusions if MAR, but not if non-ignorable missing analysis Robust to choice of case distribution (cancer, benign, recall, normal) 59

60 Next Speaker The next speaker is Dr. Gary Levine 60

61 Radiology Advisory Panel Meeting Hologic Selenia Dimensions 3D System with C-View Software Module FDA Clinical Perspective Gary Levine, MD, MSE Mammography, Ultrasound, and Imaging Software Branch Division of Radiological Health Office of In vitro Diagnostics, and Radiological Health Center for Devices and Radiological Health Food and Drug Administration

62 Overview Clinical Significance Study Design Study Results Benefit vs. Risk Labeling and Reader Training MQSA Issues Summary 62

63 Background Tomosynthesis is the generation of slice images by digitally processing X-ray images obtained at multiple angles The synthesized 2D images are a mathematical reconstruction from the 3D image set similar to a maximum intensity projection (MIP) 63

64 Background Advantages of 3D over traditional 2D images Reduces visual clutter by removing overlying anatomic structures Allows for depth localization Original PMA approval studies support the benefits of 2D plus 3D for breast cancer screening and diagnosis 64

65 Clinical Significance 3D S is a new exam option with a radiation dose that is comparable to current FFDM Using the 3D S option could reduce the radiation exposure and compression time by eliminating the FFDM acquisition required with current 2D plus 3D exams Exam 2D FFDM Hologic 2D FFDM across manufacturers** 3D S (3D DBT plus synthesized 2D) 2D FFDM plus 3D DBT Radiation Dose* 1.2 mgy (single 2D acquisition) 1.43 mgy (single 2D acquisition) 1.45 mgy (single 3D acquisition) 2.65 mgy (2D + 3D acquisition) * Measured using a standard phantom ** Collected from medical physicists dose measurements available at the time of MQSA inspections Jan Sept

66 Study Design The study design is similar to the MRMC studies used to support the initial DBT approval Stratified sampling to obtain representative enriched dataset based on lesion type and breast density 15 Board certified and MQSA qualified radiologists Readers and cases were not used for any prior studies Non-inferiority study since the 3D S exam dose is comparable to existing average 2D FFDM dose 66

67 Study Design The study population was a mix of routine screening and patients scheduled for biopsy Cancer truth is based on biopsy results Non cancer truth required a one year follow-up mammogram Follow up on 9 of 302 cases is missing Case distribution: 77 Cancers 24 Recalled Screening Cases 75 Benign Biopsy 126 Screening Negatives 67

68 Study Results 3D S was non-inferior in ROC AUC compared with FFDM Secondary analysis indicate a reduction in the non-cancer recall rate Secondary analysis also compared 3D S to 2D FFDM across: Fatty and dense breasts Non-calcifications and calcifications Sensitivity and specificity Cancer recall rate 68

69 Benefit vs. Risk Compared with FFDM In clinical practice, 3D S may reduce the number of non-cancer recalls, thereby reducing patient anxiety and radiation dose from additional imaging However, the 3D S exam will not include the standard of care FFDM images, which will impact how mammography is performed and interpreted 69

70 Benefit vs. Risk Compared with the approved 2D FFDM plus 3D DBT option With 3D S, lower radiation dose compared to the combined 2D FFDM + 3D DBT Shorter breast compression with 3D S 70

71 Labeling and Reader Training The labeling states that the synthesized 2D are only to be used as an aid to the 3D images This reflects the intended use and study design 71

72 Labeling and Reader Training Users need to understand that the synthesized 2D is similar to, but not identical to standard of care 2D FFDM Note: The images will also contain a C-View mark The software used to create the synthesized images depends on assumptions of the breast geometry The training should include how synthesized 2D images might look different and how to account for those differences when comparing to prior FFDM exams 72

73 Labeling and Reader Training The labeling and training should inform radiologists/technologists of situations when to acquire 2D FFDM instead of using 3D S The labeling states the following situations that could result in atypical synthesized 2D images: Large artificial objects (implants, pacemakers, and port-a-caths) Diagnostic paddles Intramammary metallic markers Patient motion Mastectomy view Surgical specimen 73

74 Labeling and Reader Training The study excluded subjects with an internal breast marker, breast implants, and breasts too large to be imaged with a single exposure These situations may not match the assumptions used by the software and could result in atypical synthesized 2D images FDA expects the labeling to address that the performance of 3D S in these situations was not established 74

75 Labeling and Reader Training The study excluded subjects with previous surgical (excisional) biopsy This exclusion was by design to avoid confounding the results This exclusion is not addressed in the labeling Consideration for Panel Discussion Question #3 75

76 MQSA Requirements Tomosynthesis is being treated as a new mammographic modality requiring that: All personnel obtain 8 hours of training in that mammographic modality prior to use on patients Hologic must provide each facility with a QC manual clearly defining initial, periodic, and yearly testing requirements Facilities follow the manufacturer s quality control (QC) manual 76

77 MQSA Requirements The synthesized 2D view will not be treated as a new modality The training for the synthesized 2D views can be included as part of the 8 hour training for new users of tomosynthesis MQSA will continue using the certificate extension program for the immediate future 77

78 Summary The study design is consistent with other MRMC mammography studies Difficult to estimate the clinical benefit to risk ratio from an enriched stratified sampled study The results are non-inferior to FFDM, but indicate the likely benefit of using 3D S to reduce the recall rate The dose is comparable with current FFDM, so there is minimal additional risk 78

79 Summary Hologic needs to provide training to help new users utilize the new technology effectively FDA expects the labeling to address situations where the currently approved FFDM and/or FFDM plus DBT screening options may be more appropriate instead of 3D S 79

80 Radiology Advisory Panel Meeting Hologic Selenia Dimensions 3D System with C-View Software Module Panel Discussion Robert Ochs, PhD Branch Chief Mammography, Ultrasound, and Imaging Software Branch Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Food and Drug Administration

81 Discussion Topic #1: Potential Impact on Mammography Standard-of-care FFDM will not be acquired with the proposed 3D S (3D plus synthesized 2D) exam option FDA would like the panel to discuss aspects of performing and interpreting mammography that should be considered in the training and/or labeling For example, the panel could discuss the use of 3D S for comparing current and prior exams 81

82 Discussion Topic #2: Study Bias The study design is similar to the other MRMC studies Potential biases with the current study include: The distribution of cases (cancer, benign, recall, negative) for the non-inferiority hypothesis Cases being excluded from random selection because the image set did not pass QC criteria Lack of confirmation of 8 negatives and 1 benign as non-cancer because they were lost to follow-up FDA would like the panel to discuss any concerns with the potential sources of bias and if the presented analysis on the robustness of the results is sufficient 82

83 Discussion Topic #3: Study Exclusions The labeling addresses some study exclusions, such as breast implants that could result in atypical images However, there is no information to indicate that subjects with previous surgical (excisional) biopsy will cause atypical images In the original Hologic DBT PMA, subjects with surgical (excisional) biopsy were excluded by design to avoid confounding the results as prior patient studies and reports were not available to the reader The results were considered generalizable for the original DBT PMA since there were no technical concerns with imaging these subjects and the FFDM images would still be available FDA would like the panel to discuss the generalizability of 3D S to subjects with previous surgical (excisional) biopsy 83

84 Discussion Topic #4 The panel is also asked to discuss any other concerns with respect to the safety, effectiveness, or benefit/risk associated with the proposed expansion to the indications for use 84

85 Radiology Advisory Panel Meeting Hologic Selenia Dimensions 3D System with C-View Software Module Panel Discussion Questions

86 Question #1 Hologic is proposing a new screening option that does not include the acquisition of standard of care FFDM images. Please discuss aspects of performing and interpreting mammography that should be considered in the training and/or labeling when FFDM images are not acquired during the screening exam. 86

87 Question #2 Does the panel have concerns with specific sources of potential bias, such as the case distribution, missing follow-up cases, and exclusions? Does the panel believe the presented analysis of these biases is sufficient? 87

88 Question #3 The study protocol excluded subjects with previous surgical (excisional) biopsy. Does the panel have concerns with the generalizability of 3D S to subjects with previous surgical (excisional) biopsy? 88

89 Question #4 Please discuss any other concerns with respect to the safety, effectiveness, or benefit/risk associated with the proposed expansion to the indications for use. 89

Hologic Selenia Dimensions C-View Software Module. October 24, 2012

Hologic Selenia Dimensions C-View Software Module. October 24, 2012 Hologic Selenia Dimensions C-View Software Module October 24, 2012 Introduction and Agenda Peter Soltani, Ph.D. Senior VP & GM, Breast Health Hologic, Inc. Agenda Technology Overview Clinical Overview

More information

P080003/S001 Hologic Selenia Dimensions C-View Software Module. Glossary of Terms

P080003/S001 Hologic Selenia Dimensions C-View Software Module. Glossary of Terms Glossary of Terms 2D plus 3D images a set of images that allow radiology is compare the results of a standard 2D mammogram image and the corresponding 3D tomosynthesis image, while viewing them independently

More information

UNITED STATES OF AMERICA FOOD AND DRUG ADMINISTRATION + + + + + + RADIOLOGICAL DEVICES PANEL + + + October 24, 2012 8:00 a.m.

UNITED STATES OF AMERICA FOOD AND DRUG ADMINISTRATION + + + + + + RADIOLOGICAL DEVICES PANEL + + + October 24, 2012 8:00 a.m. 1 1 UNITED STATES OF AMERICA DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION + + + CENTER FOR DEVICES AND RADIOLOGICAL HEALTH MEDICAL DEVICES ADVISORY COMMITTEE + + + RADIOLOGICAL

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

Role of the Medical Physicist in Clinical Implementation of Breast Tomosynthesis

Role of the Medical Physicist in Clinical Implementation of Breast Tomosynthesis Role of the Medical Physicist in Clinical Implementation of Breast Tomosynthesis Bob Liu, Ph.D. Department of Radiology Massachusetts General Hospital And Harvard Medical School Digital Breast Tomosynthesis

More information

Mammography. What is Mammography?

Mammography. What is Mammography? Scan for mobile link. Mammography Mammography is a specific type of breast imaging that uses low-dose x-rays to detect cancer early before women experience symptoms when it is most treatable. Tell your

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

Q: What differentiates a diagnostic from a screening mammography procedure?

Q: What differentiates a diagnostic from a screening mammography procedure? The following Q&As address Medicare guidelines on the reporting of breast imaging procedures. Private payer guidelines may vary from Medicare guidelines and from payer to payer; therefore, please be sure

More information

Methodologies for Evaluation of Standalone CAD System Performance

Methodologies for Evaluation of Standalone CAD System Performance Methodologies for Evaluation of Standalone CAD System Performance DB DSFM DCMS OSEL DESE DP DIAM Berkman Sahiner, PhD USFDA/CDRH/OSEL/DIAM AAPM CAD Subcommittee in Diagnostic Imaging CAD: CADe and CADx

More information

Great Strides MARKEY COMPREHENSIVE BREAST CARE CENTER: SETTING A NEW STANDARD OF CARE

Great Strides MARKEY COMPREHENSIVE BREAST CARE CENTER: SETTING A NEW STANDARD OF CARE Great Strides MARKEY COMPREHENSIVE BREAST CARE CENTER: SETTING A NEW STANDARD OF CARE Markey Cancer Center s Comprehensive Breast Care Center is the first health care provider in Kentucky to offer new

More information

Fundamentals of Breast Tomosynthesis

Fundamentals of Breast Tomosynthesis 78967-12_WP-00007_FundmntlsTomo 10/3/12 3:47 PM Page 1 Fundamentals of Breast Tomosynthesis Improving the Performance of Mammography Andrew Smith, Ph.D. This white paper is one in a series of research

More information

2014 Meeting of Mid-Atlantic States Radiation Control Programs March 25, 2014

2014 Meeting of Mid-Atlantic States Radiation Control Programs March 25, 2014 2014 Meeting of Mid-Atlantic States Radiation Control Programs March 25, 2014 Interpreting Physicians Final Requirements for Interpreting Physicians Meet Initial Qualifications License Certification OR

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

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

Breast Imaging Protocol Eastern Radiologists, Inc. Breast Imaging Network

Breast Imaging Protocol Eastern Radiologists, Inc. Breast Imaging Network Breast Imaging Protocol Eastern Radiologists, Inc. Breast Imaging Network Screening Mammography Images: Routine CC and MLO views, XCCL if needed. Implant Patients: CC and MLO in both routine and implant

More information

Appropriate Imaging for Breast Cancer Screening in Special Populations

Appropriate Imaging for Breast Cancer Screening in Special Populations Health Technology Assessment Appropriate Imaging for Breast Cancer Screening in Special Populations Draft Evidence Report: & December 10, 2014 Health Technology Assessment Program (HTA) Washington State

More information

Quality Control of Full Field Digital Mammography Units

Quality Control of Full Field Digital Mammography Units Quality Control of Full Field Digital Mammography Units Melissa C. Martin, M.S., FACMP, FACR, FAAPM Melissa@TherapyPhysics.com 310-612-8127 ACMP Annual Meeting Virginia Beach, VA May 2, 2009 History of

More information

American College of Radiology Mammography Accreditation Program

American College of Radiology Mammography Accreditation Program American College of Radiology Mammography Accreditation Program Objectives Overview of the ACR Mammography Accreditation Program Interrelationship between mammography accreditation, FDA certification and

More information

Sustaining a High-Quality Breast MRI Practice

Sustaining a High-Quality Breast MRI Practice Sustaining a High-Quality Breast MRI Practice Christoph Lee, MD, MSHS Associate Professor of Radiology Adjunct Associate Professor, Health Services University of Washington September 11, 2015 Overview

More information

Personalized Breast Screening Service

Personalized Breast Screening Service Frequently Asked Questions WHAT IS BREAST DENSITY? Breasts are made up of a mixture of fibrous, glandular and fatty tissue. Your breasts are considered if you have predominantly fibrous or glandular tissue

More information

Medicare Part B. Mammograms - Updated Billing Guide for Screening and Diagnostic Tests

Medicare Part B. Mammograms - Updated Billing Guide for Screening and Diagnostic Tests Mammograms - Updated Billing Guide for Screening and Diagnostic Tests This article from Medicare B News Issue 223 dated October 21, 2005 is being updated and reprinted to ensure that the Noridian Administrative

More information

National Medical Policy

National Medical Policy National Medical Policy Subject: Breast Tomosynthesis (Digital), 3-D Mammography Policy Number: NMP 526 Effective Date: December 2013 Update: April 2016 This National Medical Policy is subject to the terms

More information

Harlem Hospital Center Integrated Radiology Residency Program Mammography Educational goals and objectives

Harlem Hospital Center Integrated Radiology Residency Program Mammography Educational goals and objectives Harlem Hospital Center Integrated Radiology Residency Program Mammography Educational goals and objectives Rotation 1 (Radiology year 1/2) Knowledge Based Objectives: At the end of the rotation, the resident

More information

MQSA and ACR Digital Breast Tomosynthesis Mammography Accreditation

MQSA and ACR Digital Breast Tomosynthesis Mammography Accreditation US FFDM Mammography Facilities and Units MQSA and ACR Digital Breast Tomosynthesis Mammography Accreditation Pamela L. Platt, BSRT(R)(M)(CV) FDA Liaison, ACR Breast Imaging Accreditation Program In 2000

More information

(1) Interpreting physicians. All physicians interpreting mammograms shall meet the following qualifications:

(1) Interpreting physicians. All physicians interpreting mammograms shall meet the following qualifications: DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 900 Quality Mammography Standards Subpart B Quality Standards and Certification Sec. 900.12 Quality standards. (a) Personnel.

More information

American College of Radiology Stereotactic Breast Biopsy Accreditation Program

American College of Radiology Stereotactic Breast Biopsy Accreditation Program American College of Radiology Stereotactic Breast Biopsy Program ACR Breast Imaging Programs June 2003 Mammography required under MQSA 8251 facilities; 12,077 units accredited Stereotactic Breast Biopsy

More information

Stereoscopic vs. monoscopic detection of masses on breast tomosynthesis projection images

Stereoscopic vs. monoscopic detection of masses on breast tomosynthesis projection images Stereoscopic vs. monoscopic detection of masses on breast tomosynthesis projection images Gautam S. Muralidhar* a, Tejaswini Ganapathi b, Alan C. Bovik b, Mia K. Markey a,c, Tamara Miner Haygood d, Tanya

More information

MQSA, FDA Regulations, and Inspections

MQSA, FDA Regulations, and Inspections The American College of Radiology Mammography Accreditation Program: Frequently Asked Questions (Updated: December 15, 2015) Table of Contents MQSA, FDA Regulations, and Inspections... 2 ACR Mammography

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

Update on MQSA and ACR Mammography Accreditation

Update on MQSA and ACR Mammography Accreditation MQSA - Who s Who Update on MQSA and ACR Mammography Accreditation The Law: Mammography Quality Standards Act (MQSA) The Regulator: US Food and Drug Administration (FDA) Pamela L. Platt, BSRT(R)(M)(CV)

More information

BREAST IMAGING. Developed by the Ad Hoc Committee on Resident and Fellow Education of the Society of Breast Imaging

BREAST IMAGING. Developed by the Ad Hoc Committee on Resident and Fellow Education of the Society of Breast Imaging BREAST IMAGING Developed by the Ad Hoc Committee on Resident and Fellow Education of the Society of Breast Imaging Stephen A. Feig, M.D., Chair Ferris Hall, M.D. Debra Ikeda, M.D. Ellen Mendelson, M.D.

More information

The American College of Radiology Stereotactic Breast Biopsy Accreditation Program: Frequently Asked Questions (Updated: August 24, 2015)

The American College of Radiology Stereotactic Breast Biopsy Accreditation Program: Frequently Asked Questions (Updated: August 24, 2015) The American College of Radiology Stereotactic Breast Biopsy Accreditation Program: Frequently Asked Questions (Updated: August 24, 2015) Table of Contents Stereotactic Breast Biopsy Accreditation Program

More information

Learning objectives. Performance of ultrasound. Many advantages of ultrasound. Elastography for evaluation of breast masses

Learning objectives. Performance of ultrasound. Many advantages of ultrasound. Elastography for evaluation of breast masses Elastography for evaluation of breast masses Learning objectives List physical principles of elastography imaging of the breast List different types of elastography imaging of the breast State results

More information

Provincial Quality Management Programs for Mammography, Colonoscopy and Pathology in Ontario

Provincial Quality Management Programs for Mammography, Colonoscopy and Pathology in Ontario Provincial Quality Management Programs for Mammography, Colonoscopy and Pathology in Ontario Quality Management Partnership Consultation Materials: Mammograp hy October 20, 2014 Table of Contents 1.0 Background

More information

A Guide to Breast Imaging: The Latest Technology for Screening and Detecting Breast Cancer

A Guide to Breast Imaging: The Latest Technology for Screening and Detecting Breast Cancer A Guide to Breast Imaging: The Latest Technology for Screening and Detecting Breast Cancer Sally Herschorn, MD Associate Professor of Radiology University of Vermont College of Medicine Medical Director

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

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

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

White Paper. Study to Demonstrate Efficacy of 8MP Color Display - Mammography 1.INTRODUCTION... 2 2.PURPOSE... 2 3.METHODS... 2 4.RESULTS...

White Paper. Study to Demonstrate Efficacy of 8MP Color Display - Mammography 1.INTRODUCTION... 2 2.PURPOSE... 2 3.METHODS... 2 4.RESULTS... White Paper Study to Demonstrate Efficacy of 8MP Color Display - Mammography CONTENTS 1.INTRODUCTION... 2 2.PURPOSE... 2 3.METHODS... 2 4.RESULTS... 3 5.CONCLUSIONS... 5 6.REPORT FROM DR. KRUPINSKI, UNIVERSITY

More information

Infrared Thermography Not a Useful Breast Cancer Screening Tool

Infrared Thermography Not a Useful Breast Cancer Screening Tool Contact: Jeanne-Marie Phillips Sharon Grutman HealthFlash Marketing The American Society of Breast Surgeons 203-977-3333 877-992-5470 Infrared Thermography Not a Useful Breast Cancer Screening Tool Mammography

More information

Mammography. For 35+ years, screenfilm has been the gold standard for breast cancer detection

Mammography. For 35+ years, screenfilm has been the gold standard for breast cancer detection Digital Mammography Upright Stereo Mammography For 35+ years, screenfilm has been the gold standard for breast cancer detection IN THE BEGINNING Mammography technology has come a long way since the first

More information

American Medical Women s Association. Position Paper on Principals of Breast Cancer Screening

American Medical Women s Association. Position Paper on Principals of Breast Cancer Screening American Medical Women s Association Position Paper on Principals of Breast Cancer Screening Breast cancer affects one woman in eight in the United States and is the most common cancer diagnosed in women

More information

Variability and Accuracy in Mammographic Interpretation Using the American College of Radiology Breast Imaging Reporting and Data System

Variability and Accuracy in Mammographic Interpretation Using the American College of Radiology Breast Imaging Reporting and Data System Variability and Accuracy in Mammographic Interpretation Using the American College of Radiology Breast Imaging Reporting and Data System Karla Kerlikowske, Deborah Grady, John Barclay, Steven D. Frankel,

More information

Digital Mammography Update: Design and Characteristics of Current Systems

Digital Mammography Update: Design and Characteristics of Current Systems : Design and Characteristics of Current Systems Kalpana M. Kanal, Ph.D., DABR Assistant Professor Department of Radiology University of Washington Seattle, Washington AAPM Annual Meeting 2009 Anaheim,

More information

PEER REVIEW HISTORY ARTICLE DETAILS TITLE (PROVISIONAL)

PEER REVIEW HISTORY ARTICLE DETAILS TITLE (PROVISIONAL) PEER REVIEW HISTORY BMJ Open publishes all reviews undertaken for accepted manuscripts. Reviewers are asked to complete a checklist review form (http://bmjopen.bmj.com/site/about/resources/checklist.pdf)

More information

2011 Radiology Diagnosis Coding Update Questions and Answers

2011 Radiology Diagnosis Coding Update Questions and Answers 2011 Radiology Diagnosis Coding Update Questions and Answers How can we subscribe to the Coding Clinic for ICD-9 guidelines and updates? The American Hospital Association publishes this quarterly newsletter.

More information

breast imaging solutions Understanding ImageChecker CAD 10.0

breast imaging solutions Understanding ImageChecker CAD 10.0 breast imaging solutions Understanding ImageChecker CAD 10.0 User Guide MAN-03682 rev 002 Understanding ImageChecker CAD 10.0 User Guide MAN-03682 Rev 002 Technical Support In North America contact: Toll

More information

Surveying and QC of Stereotactic Breast Biopsy Units for ACR Accreditation

Surveying and QC of Stereotactic Breast Biopsy Units for ACR Accreditation Surveying and QC of Stereotactic Breast Biopsy Units for ACR Accreditation LORAD Stereotactic Breast Biopsy System AAPM Spring Clinical Meeting Phoenix, AZ March 17, 2013 Melissa C. Martin, M.S., FACR,

More information

Radiology Physician Performance Measurement Set

Radiology Physician Performance Measurement Set American College of Radiology/ Physician Consortium for Performance Improvement / National Committee for Quality Assurance Radiology Physician Performance Measurement Set October 2007 Radiology Work Group

More information

The Mammography Quality Standards Act Final Regulations Document #1

The Mammography Quality Standards Act Final Regulations Document #1 Compliance Guidance The Mammography Quality Standards Act Final Regulations Document #1 Document issued on: March 19, 1999 This document supersedes document Draft Compliance Guidance August 27, 1998 U.S.

More information

On the matter of size and distance measurements in digital mammography David A. Clunie 2007/03/18

On the matter of size and distance measurements in digital mammography David A. Clunie 2007/03/18 On the matter of size and distance measurements in digital mammography David A. Clunie 2007/03/18 Radiologists reading mammograms have a need to measure size and distance in order to estimate interval

More information

Personalized Predictive Medicine and Genomic Clinical Trials

Personalized Predictive Medicine and Genomic Clinical Trials Personalized Predictive Medicine and Genomic Clinical Trials Richard Simon, D.Sc. Chief, Biometric Research Branch National Cancer Institute http://brb.nci.nih.gov brb.nci.nih.gov Powerpoint presentations

More information

Breast Imaging East Duarte Road Duarte, CA HOPE MED M

Breast Imaging East Duarte Road Duarte, CA HOPE  MED M Breast Imaging 1500 East Duarte Road Duarte, CA 91010-3000 800.826.HOPE www.cityofhope.org MED 8116 0607 25M Breast Imaging Benefits of Early Detection One out of eight women in the U.S. will develop breast

More information

ASPIRATION OF PALPABLE CYST

ASPIRATION OF PALPABLE CYST CYSTS ASPIRATION OF PALPABLE CYST GALACTOCELE New lump in nursing mother-soft to firm non-tender Treatment Aspiration FAT NECROSIS Usually there is a history of trauma - MVA, surgery. The fat dies and

More information

Breast cancer close to the nipple: Does this carry a higher risk ofaxillary node metastasesupon diagnosis?

Breast cancer close to the nipple: Does this carry a higher risk ofaxillary node metastasesupon diagnosis? Breast cancer close to the nipple: Does this carry a higher risk ofaxillary node metastasesupon diagnosis? Erin I. Lewis, BUSM 2010 Cheri Nguyen, BUSM 2008 Priscilla Slanetz, M.D., MPH Al Ozonoff, Ph.d.

More information

Breast Density Legislation: Implications for primary care providers

Breast Density Legislation: Implications for primary care providers Breast Density Legislation: Implications for primary care providers Deborah J. Rhodes MD Associate Professor of Medicine 2012 MFMER slide-1 Disclosure Relevant financial relationship(s) None Off-label

More information

The Product Review Life Cycle A Brief Overview

The Product Review Life Cycle A Brief Overview Stat & Quant Mthds Pharm Reg (Spring 2, 2014) Lecture 2,Week 1 1 The review process developed over a 40 year period and has been influenced by 5 Prescription User Fee Act renewals Time frames for review

More information

Driving Forces in Health Care:

Driving Forces in Health Care: : Take This Job and Love It! Peggy Hoosier, M.Ed., RT (R) (M) Sr. Vice President of Professional Education Advanced Health Education Center,Ltd. 2011 State of 2011 Driving Forces in Health Care: Money

More information

Allegheny Health Network. Breast Care Center

Allegheny Health Network. Breast Care Center Allegheny Health Network Breast Care Center Breast health is a top priority of every woman. At Allegheny Health Network, you ll find a full array of breast care services designed with your needs in mind.

More information

ACR BI-RADS ATLAS MAMMOGRAPHY MAMMOGRAPHY II. REPORTING SYSTEM. American College of Radiology 121

ACR BI-RADS ATLAS MAMMOGRAPHY MAMMOGRAPHY II. REPORTING SYSTEM. American College of Radiology 121 ACR BI-RADS ATLAS II. REPORTING SYSTEM American College of Radiology 121 2013 122 American College of Radiology ACR BI-RADS ATLAS A. REPORT ORGANIZATION (Guidance chapter, see page 147) The reporting system

More information

FFR CT : Clinical studies

FFR CT : Clinical studies FFR CT : Clinical studies Bjarne Nørgaard Department Cardiology B Aarhus University Hospital Skejby, Denmark Disclosures: Research grants: Edwards and Siemens Coronary CTA: High diagnostic sensitivity

More information

The American College of Radiology Breast Ultrasound Accreditation Program: Frequently Asked Questions

The American College of Radiology Breast Ultrasound Accreditation Program: Frequently Asked Questions The American College of Radiology Breast Ultrasound Accreditation Program: Frequently Asked Questions Table of Contents APPLICATION - GENERAL... 1 MOVED FACILITIES AND UNITS... 3 EQUIPMENT... 4 PERSONNEL...

More information

Digital Tomosynthesis: Advanced Breast Cancer Imaging Technique. Max Wiedmann

Digital Tomosynthesis: Advanced Breast Cancer Imaging Technique. Max Wiedmann Digital Tomosynthesis: Advanced Breast Cancer Imaging Technique Max Wiedmann Digital Tomosynthesis An imaging technique in which multiple X-rays of one object are take from a discrete number angles. These

More information

FDA Regulation of Whole Slide Imaging (WSI) Devices: Current Thoughts

FDA Regulation of Whole Slide Imaging (WSI) Devices: Current Thoughts FDA Regulation of Whole Slide Imaging (WSI) Devices: Current Thoughts Clinical Laboratory Improvement Advisory Committee Meeting Centers for Disease Control and Prevention February 15, 2012 Tremel A. Faison,

More information

IAC Ch 41, p.1. Procedure means a stereotactically guided breast biopsy performed on a patient for diagnostic purposes.

IAC Ch 41, p.1. Procedure means a stereotactically guided breast biopsy performed on a patient for diagnostic purposes. IAC Ch 41, p.1 641 41.7 (136C) X-ray machines used for stereotactically guided breast biopsy. 41.7(1) Definitions. In addition to the definitions provided in rules 641 38.2(136C), 641 40.2(136C), and 641

More information

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

Patient Prep Information

Patient Prep Information Stereotactic Breast Biopsy Patient Prep Information Imaging Services Cannon Memorial Hospital Watauga Medical Center Table Weight Limits for each facility Cannon Memorial Hospital Watauga Medical Center

More information

Prototype Internet consultation system for radiologists

Prototype Internet consultation system for radiologists Prototype Internet consultation system for radiologists Boris Kovalerchuk, Department of Computer Science, Central Washington University, Ellensburg, WA 98926-7520, USA borisk@tahoma.cwu.edu James F. Ruiz

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

Digital Mammogram National Database

Digital Mammogram National Database Digital Mammogram National Database Professor Michael Brady FRS FREng Medical Vision Laboratory Oxford University Chairman: Mirada Solutions Ltd PharmaGrid 2/7/03 ediamond aims construct a federated database

More information

A Breakthrough in Breast Specimen Imaging

A Breakthrough in Breast Specimen Imaging BreAST HEALTH SOLUTIONS A Breakthrough in Breast Specimen Imaging Trident Specimen Radiography System Superb Image Quality for Streamlined Workflow The Trident system s sharp, high quality images allow

More information

First Warning Systems, Inc.

First Warning Systems, Inc. First Warning Systems, Inc. Breast Cancer Early Detection System US EU/UK & Russia Executive Summary September 2012 i 1. EXECUTIVE SUMMARY 1.1 FIRST WARNING SYSTEM INTRODUCTION First Warning System (FWS)

More information

Breast Health Program

Breast Health Program Breast Health Program Working together, for your health. Breast Health Program The Breast Health Program at The University of Arizona Cancer Center offers patients a personalized approach to breast cancer,

More information

Coronis 5MP Mammo. The standard of care for digital mammography

Coronis 5MP Mammo. The standard of care for digital mammography Coronis 5MP Mammo The standard of care for digital mammography The standard of care For thousands of women every day, details make all the difference. This understanding, along with many years of commitment

More information

Screening Mammography Program of BC

Screening Mammography Program of BC Screening Mammography Program of BC Dr. Christine M. Wilson MD FRCPC Medical Director, Screening Mammography Program BC Cancer Agency March 19, 2015 Disclosure The presenter, Dr. Christine M. Wilson, has

More information

DICOM Grid, Inc. January 25, 2016. Senior Consultant Biologics Consulting Group, Inc. 400 N. Washington Street, Suite 100 ALEXANDRIA VA 22314

DICOM Grid, Inc. January 25, 2016. Senior Consultant Biologics Consulting Group, Inc. 400 N. Washington Street, Suite 100 ALEXANDRIA VA 22314 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center WO66-G609 Silver Spring, MD 20993-0002 DICOM Grid, Inc. Senior

More information

ACR AAPM SIIM PRACTICE PARAMETER FOR DETERMINANTS OF IMAGE QUALITY IN DIGITAL MAMMOGRAPHY

ACR AAPM SIIM PRACTICE PARAMETER FOR DETERMINANTS OF IMAGE QUALITY IN DIGITAL MAMMOGRAPHY The American College of Radiology, with more than 30,000 members, is the principal organization of radiologists, radiation oncologists, and clinical medical physicists in the United States. The College

More information

Digital Breast Tomosynthesis QC Requirements

Digital Breast Tomosynthesis QC Requirements Digital Breast Tomosynthesis QC Requirements AAPM Spring Clinical Meeting March 8, 2015 Michael S Glaser, MS, DABR Alliance Medical Physics, LLC Learning Objectives 1. GE SenoClaire - Physicist & Technologist

More information

Update on ACR Digital Mammography QC Manual

Update on ACR Digital Mammography QC Manual Update on ACR Digital Mammography QC Manual Priscilla F. Butler, M.S. Medical Physicist and Senior Director, ACR, Reston, VA (with thanks to Eric Berns, Ph.D.) Overview Phantom Specifications QC Manual

More information

BREAST CHARACTERISTICS AND DOSIMETRIC DATA IN X RAY MAMMOGRAPHY - A LARGE SAMPLE WORLDWIDE SURVEY

BREAST CHARACTERISTICS AND DOSIMETRIC DATA IN X RAY MAMMOGRAPHY - A LARGE SAMPLE WORLDWIDE SURVEY BREAST CHARACTERISTICS AND DOSIMETRIC DATA IN X RAY MAMMOGRAPHY - A LARGE SAMPLE WORLDWIDE SURVEY N. GEERAERT a,b,c, R. KLAUSZ a, S. MULLER a, I. BLOCH c, H. BOSMANS b a GE Healthcare, Buc, France b Department

More information

CONSOLIDATED GUIDANCE ON STANDARDS FOR THE NHS BREAST SCREENING PROGRAMME

CONSOLIDATED GUIDANCE ON STANDARDS FOR THE NHS BREAST SCREENING PROGRAMME CONSOLIDATED GUIDANCE ON STANDARDS FOR THE NHS BREAST SCREENING PROGRAMME NHSBSP Publication No 60 (Version 2) April 2005 Published by: NHS Cancer Screening Programmes The Manor House 260 Ecclesall Road

More information

Clinical trials for medical devices: FDA and the IDE process

Clinical trials for medical devices: FDA and the IDE process Clinical trials for medical devices: FDA and the IDE process Owen Faris, Ph.D. Deputy Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health,

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

BREAST IMAGING SOLUTIONS. Integrated Breast Imaging Workflow Solutions

BREAST IMAGING SOLUTIONS. Integrated Breast Imaging Workflow Solutions BREAST IMAGING SOLUTIONS Integrated Breast Imaging Workflow Solutions Seamless Workflow Solutions Customized to Your Needs Hologic understands that a well structured connectivity plan benefits your whole

More information

Breast MRI Quality Control

Breast MRI Quality Control Donna M. Reeve, MS, DABR, DABMP Department of Imaging Physics Educational Objectives Discuss the importance of breast MRI quality control (QC). Provide an overview of the new ACR Breast MRI Accreditation

More information

Provincial Quality Management Programs for Mammography, Colonoscopy and Pathology in Ontario

Provincial Quality Management Programs for Mammography, Colonoscopy and Pathology in Ontario Provincial Quality Management Programs for Mammography, Colonoscopy and Pathology in Ontario Quality Management Partnership Consultation Materials: Heal th System Ad mi nistrato r s October 20, 2014 Table

More information

Illinois Insurance Facts Illinois Department of Insurance Coverage for the Diagnosis and Treatment of Breast Conditions

Illinois Insurance Facts Illinois Department of Insurance Coverage for the Diagnosis and Treatment of Breast Conditions Illinois Insurance Facts Illinois Department of Insurance Coverage for the Diagnosis and Treatment of Breast Conditions Revised May 2015 Note: This information was developed to provide consumers with general

More information

SFHM6 Undertake localisation procedure in the breast using X-ray guidance

SFHM6 Undertake localisation procedure in the breast using X-ray guidance Undertake localisation procedure in the breast using X-ray guidance Overview This standard is concerned with the use of x-ray guided equipment to locate regions in the breast perceived to be abnormal.

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

Office Visits. Breast

Office Visits. Breast Early Detection Works Reimbursement Fee Schedule Effective for services on or after July 1, 2015 Program guidelines require that be the payor of last resort. Program funds cannot be used to supplement

More information

Having a Breast Biopsy. A Guide for Women and Their Families

Having a Breast Biopsy. A Guide for Women and Their Families Having a Breast Biopsy A Guide for Women and Their Families Fast Facts n n Most women who have a breast biopsy do not have breast cancer. About 4 out of every 5 breast biopsies are negative for cancer.

More information

Breast Health Center

Breast Health Center Breast Health Center Our Breast Health Center, part of Cleveland Clinic s Comprehensive Breast Cancer Program, is committed to providing compassionate care to every woman. We have state-of-the-art treatment

More information

DATE NAME: DOB: / / AGE: EMAIL ADDRESS: CELL PHONE NUMBER/BEST CONTACT NUMBER: REFERRING PHYSICIAN: EMERGENCY CONTACT NAME, PHONE NUMBER

DATE NAME: DOB: / / AGE: EMAIL ADDRESS: CELL PHONE NUMBER/BEST CONTACT NUMBER: REFERRING PHYSICIAN: EMERGENCY CONTACT NAME, PHONE NUMBER Mammosafe 5300 North Braeswood Boulevard Suite 4-400 Houston, Texas 77096 832.975.7824 BREAST HISTORY FORM DATE NAME: DOB: / / AGE: EMAIL ADDRESS: CELL PHONE NUMBER/BEST CONTACT NUMBER: REFERRING PHYSICIAN:

More information

What do we do about mammographic density?

What do we do about mammographic density? What do we do about mammographic density? Sarah Vinnicombe Clinical Senior Lecturer in Cancer Imaging Ninewells Hospital Medical School s.vinnicombe@dundee.ac.uk Risk Factors for Breast Cancer Genetic

More information

Clinical Trial Designs for Firstline Hormonal Treatment of Metastatic Breast Cancer

Clinical Trial Designs for Firstline Hormonal Treatment of Metastatic Breast Cancer Clinical Trial Designs for Firstline Hormonal Treatment of Metastatic Breast Cancer Susan Honig, M.D. Patricia Cortazar, M.D. Rajeshwari Sridhara, Ph.D. Acknowledgements John Johnson Alison Martin Grant

More information

Supports screening, diagnostic, and multimodality workflows

Supports screening, diagnostic, and multimodality workflows GE Healthcare Universal Viewer Breast Imaging Product Data Sheet Supports screening, diagnostic, and multimodality workflows Introduction Centricity PACS with Universal Viewer 1 puts clinical insight within

More information

Sample Size Planning, Calculation, and Justification

Sample Size Planning, Calculation, and Justification Sample Size Planning, Calculation, and Justification Theresa A Scott, MS Vanderbilt University Department of Biostatistics theresa.scott@vanderbilt.edu http://biostat.mc.vanderbilt.edu/theresascott Theresa

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

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

Contract: FIGM-CT-2000-00061. Measures for Optimising Radiological Information and Dose in Digital Imaging and Interventional Radiology (DIMOND III)

Contract: FIGM-CT-2000-00061. Measures for Optimising Radiological Information and Dose in Digital Imaging and Interventional Radiology (DIMOND III) Contract: FIGM-CT-2000-00061 Measures for Optimising Radiological Information and Dose in Digital Imaging and Interventional Radiology (DIMOND III) Introduction The DIMOND III project has supported and

More information