JULY 2008 SURETOUCH. HEALTH TECHNOLOGY ASSESSMENT SECTION MEDICAL DEVELOPMENT DIVISION MINISTRY OF HEALTH i MALAYSIA 013/08

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1 JULY 2008 SURETOUCH HEALTH TECHNOLOGY ASSESSMENT SECTION MEDICAL DEVELOPMENT DIVISION MINISTRY OF HEALTH i MALAYSIA 013/08

2 DISCLAIMER Technology review is a brief report, prepared on an urgent basis, which draws on restricted reviews from analysis of pertinent literature, on expert opinion and / or regulatory status where appropriate. It is not subjected to an external review process. While effort has been made to do so, this document may not fully reflect all scientific research available. Additionally, other relevant scientific findings may have been reported since completion of this review. Please contact: htamalaysia@moh.gov.my, if you would like further information. Health Technology Assessment Section (MaHTAS) Medical Development Division Ministry of Health Malaysia Level 4, Block E1, Precinct 1 Government Office Complex Putrajaya. Tel: Fax: Available at the following website: ii

3 Prepared by: Dr Mohd Aminuddin Mohd Yusof Principal Assistant Director Health Technology Assessment Section Ministry of Health Reviewed by: Datin Dr Rugayah Bakri Deputy Director Health Technology Assessment Section Ministry of Health iii

4 EXECUTIVE SUMMARY 1. INTRODUCTION Breast Cancer is a leading cause of death worldwide and about one in 19 women in Malaysia are at risk of getting the cancer. According to World Health Organization, strategies to reduce and control cancer include early detection. A new technology known as Palpation Imaging (PI) or Tactile Imaging (TI) has been developed for this purpose. 2. TECHNICAL FEATURES SureTouch uses the PI/TI technology to screen Breast Cancer and depicts the Clinical Breast Examination objectively, accurately and reliably. The findings are electronically displayed and documented. SureTouch is a fully integrated tactile sensing and visual mapping system and the main components are hand-held tactile receptor, portable microcomputer, calibration scale and sheath. 3. CONCLUSION There were very limited quality evidences to support the effectiveness and costeffectiveness of Palpation/Tactile Imaging and none on its safety aspect. The retrievable evidences showed that it has reasonable sensitivity, specificity and PPV. It could also characterize and differentiate between benign and malignant breast lesions, and improve communication between health care providers in the management of such condition. 4. RECOMMENDATION More scientific evidences are required to support the effectiveness, safety and costeffectiveness of SureTouch and similar technologies. However, it can be recommended as a research tool in the screening of Breast Cancer. iv

5 SURETOUCH 1. INTRODUCTION Cancer is a leading cause of death worldwide and accounted for 13% of all deaths in Breast cancer is among the top five causes of cancer deaths each year and it is the top most cause among women worldwide. About 80% of all cancer deaths in 2007 occurred in low- and middle-income countries. In Malaysia, about one in 19 women in this country are at risk, compared to one in eight in Europe and the United States. 2 According to World Health Organization, cancer can be reduced and controlled by implementing evidence-based strategies for cancer prevention, early detection of cancer and management of patients with cancer. 1 In fact, one-third of the cancer burden could be reduced if cases were detected and treated early when treatment is more effective. There are two components of early detection efforts. These include i. education on recognizing early signs of cancer and seeking prompt medical attention ii. screening programmes to identify early cancer or pre-cancer before signs are recognizable. There are a number of screening methods and the established ones are breast selfexamination, clinical breast examination (CBE) and mammogram. 3 Other screening modalities include ultrasonography, Magnetic Resonance Imaging (MRI), scintimammography and tissue sampling. 4 For screening of Breast Cancer, the U.S. Preventive Services Task Force (USPSTF) has recommended that the evidence is insufficient to recommend for or against routine CBE alone to screen for breast cancer. 5 All this while, documentation of findings in a CBE has been done using simple handdrawings and stick figures and these, together with the descriptive terms, are subjectively done and user dependent. This may lead to different interpretations by different observers. In fact, the subjective or non-standardized drawings may not communicate the same examination to a second examiner or even to the same examiner later. These include the estimated sizes of masses palpated by each clinician. Thus, there is a need to objectively document the clinical findings to ease communication between the clinicians and also between clinician and the patients. A new technology known as Palpation Imaging (PI) or Tactile Imaging (TI) has been developed for this purpose. The technology review on SureTouch and the technology it uses was requested by Senior Private Secretary to the Health Minister of Malaysia. 2. OBJECTIVE To assess the effectiveness, safety and cost-effectiveness of SureTouch or Palpation/Tactile Imaging. 3. TECHNICAL FEATURES Breast cancer screening is a necessity. The many competing modalities/technologies used for the purpose have their own advantages and disadvantages. 3 A programme to encourage breast self-examination alone would not reduce mortality from breast cancer. 1

6 The same thing goes with CBE although there are indications that good CBE by specially trained health workers could have an important role. Mammography is an effective screening programme but it is an expensive test and requires expertise both to perform and in the interpretation of results. In fact, it should not be introduced for screening unless the resources are available to ensure effective and reliable screening of at least 70% of the target age group. There is little evidence to support the use of ultrasound in population breast cancer screening at any age. 4 On the other hand, breast MRI is a more sensitive modality for breast cancer detection as compared with screening mammography, but it is also less specific. In one of its recommendations, the USPSTF recommends that screening mammography, with or without CBE, to be done in every 1-2 years for women aged 40 and older. 5 Some breast cancer may take months to years to grow large enough to be felt. In such situation, the SureTouch Pre-Mammogram Instrument is claimed to be able to screen for the abnormal growth and electronically see them before they can be palpated. 6 For lumps that have been already discovered, the device helps to locate exactly where the lump is and assists the examiner to determine if it is an abnormality that requires further investigation and/or additional diagnosis. SureTouch is used as part of a CBE and this produces results that are supposedly quantifiable, repeatable, and electronically documented. 6, 7 The imaging device uses Palpation Imaging (PI) or Tactile Imaging (TI) technology to depict and translate palpation findings into digital format. It yields 2D and 3D maps of tissue elasticity and provides quantitative characterization of a detected pathology. For example, upon finding a mass, the clinician notes the location of the mass within the breast. Using SureTouch, the mass characteristics of size (in at least 2 dimensions), hardness, shape, and homogeneity are scanned and re-created in a real-time display (image) in the digital form in the computer. The examination video and still-frame images are available for printed reports or single images may be incorporated into a consultation letter. The main components of SureTouch are:- a. Hand-held tactile receptor which has tactile sensors (pressure transducers) up to four times as sensitive as human touch and able to accurately map lesions as small as 5mm. The sensors produce a digital signal as they are pressed and moved against the breast tissue. The image is then reflected on the computer screen as a visual map of the breast and if a mass is detected, it will electronically show its estimated size, shape, hardness and location. b. Console or lightweight, portable micro-computer with software which can visualize the breast examination in real-time and produce prints plus save customizable reports (including breast map i.e. 2D colour map and colour mesh plot of a detected abnormality). It reconstructs the internal structure of soft tissues using the data obtained by a pressure sensor array pressed against the examined site. c. Calibration scale which enables the clinician to set and adjust the palpation pressure d. Sheath i.e. sterile disposable material that cover the sensor area of the probe 2

7 Laptop component of SureTouch 6 Screening for breast cancer using SureTouch device 6 Breast examination report produced via SureTouch 6 The device, with its fully integrated tactile sensing and visual mapping system, is manufactured by Medical Tactile Inc. of Los Angeles and has been on the market since late It is used in USA, Mexico, Ecuador, South Africa, Netherlands, United Kingdom, Australia and New Zealand. 3

8 4. METHODOLOGY 4.1 Search Methods Literatures were searched through electronic databases specifically PubMed, Cochrane, INAHTA, Horizon Scanning and general search engines. The search strategy used the terms, which are either used singly or in various combinations: SureTouch, "breast cancer", screen*, tactile imaging, stress imaging, mechanical imaging, "Breast Neoplasms"[Mesh], "Imaging, Three-Dimensional"[Mesh], "Elasticity Imaging Techniques"[Mesh], Visual Mapping System, digital sensing device, premammogram instrument, palpation image, digital breast exam, real-time palpation imaging and screening.. No limit was applied in the search. 4.2 Selection of studies All primary and secondary papers pertaining to SureTouch and its technology e.g. TI were included in this technology review. A critical appraisal of all relevant literatures was performed and the evidence level graded according to the US/Canadian Preventive Services Task Force (Appendix 1). 5. RESULTS AND DISCUSSION 5.1 Effectiveness There were limited number of articles retrieved on the technology used by SureTouch. All four studies were diagnostic tests of cross-sectional in study design. A small experimental study was conducted in 2004 and looked into the ability to detect breast nodules in phantoms with and without the tactile breast imaging (TBI) in breast examination. 8 The TBI device used in the study was a hand-held electronic palpation device which was developed at Astann Laboratories. For manual examination by skilled participants, the sensitivity was 0.85, specificity was 0.99, positive predictive value (PPV) was 1.00 and negative predictive value (NPV) was However, using TBI in the examination, the sensitivity was 0.83, specificity was 0.94, PPV was 0.98 and PNV was Though the values of the variables reduced slightly with TBI, the technology had the potential of detecting palpable breast lumps if the phantom findings can be duplicated in vivo. It may be difficult to detect a breast mass or its changes by physical examination. This may indicate biopsy and other diagnostic procedures, even if the mass is unchanged or was previously proven nonmalignant. This issue was addressed in a small prospective diagnostic study on the effectiveness of TI on breast masses, as compared to clinical examination or ultrasonography which was conducted in Level II-3 It compared the mass size estimates from preoperative physical examination, ultrasound, and TI with postoperative measurements of the resected masses. The study showed that TI estimates were repeatable (7.5% mean SD for multiple estimates of the same mass) and had good agreement with resected measurements. The mean absolute error was 13%, and linear regression with zero intercept had a slope of In fact, the tactile maps required 20 to 40 seconds to generate, with a mean scanning time of 25 seconds. On the other hand, physical examination and ultrasound estimates had respective mean absolute errors of 46% and 34%, and regression slopes of 1.27 and The study showed that TI can 4

9 provide accurate and reproducible estimates of the size of breast masses. This capability can enhance cancer surveillance for patients with benign masses (e.g. due to scarring or fibrocystic changes) because the modality can reliably detect a difference in mass size of only a 15% change (95% confidence interval) compared with conventional physical examination. As a documentation device, PI has several benefits over current technology. Kaufman CS et.al, looked at the effectiveness of digital documentation as compared with documentation of physical examination and assessed the communication value of PI of breast mass. 10 Level II-3 The studies enrolled 110 patients with complaints of a breast mass. They were examined using PI and other modalities including CBE. Final histological and/or follow-up data was correlated with preoperative PI findings. From this study, the PI device documented palpable breast masses with high sensitivity and specificity i.e. at 88% and 88% respectively, while the CBE had lower sensitivity and specificity i.e. at 81% and 81% respectively. Of those with a true mass, PI demonstrated detection rate of the mass at 94% while CBE at 86%. For those confirmed to have Breast Cancer histologically, the Positive Predictive Value (PPV) of PI was 94% and for CBE was only 78%. The difference in detecting the cancer between the two PI and CBE was statistically significant (p<0.05). There was also direct correlation between the likelihood of palpating a mass on CBE and the PI firmness category. For example, a mass with hard constituency will likely to be palpated in CBE. However, there was no statistically significant difference between the ability of CBE and PI to identify benign breast lesions. In this study too, a survey of primary care physicians revealed that the inclusion of the PI record in a consultation note implied competence, experience, and skill by the surgeon. In fact, a reproducible record of the breast physical examination was created that allowed objective review by multiple examiners at varied times. This study, however, did not address the potential assessment bias whether the same surgeon did the CBE and PI. CBE performance and reporting approaches are known to be inconsistent. Therefore, a method that mimics CBE but with enhanced sensitivity and specificity might consequently lead to a greater screening yield. This issue was addressed in a study on clinical evaluation of Breast Mechanical Imager (BMI) for breast lesions. 11 Level II-3 It was conducted in four clinical study sites and used reports from biopsy pathological examination or ultrasound with mammography as the reference standard. The study showed that malignant breast lesions (histologically-confirmed) demonstrated increased hardness and strain hardening, reduced mobility and relative boundary length in comparison with benign lesions. Statistical analysis of BMI differentiation capability for 154 benign and 33 malignant lesions revealed an average sensitivity of 89.4% ± 7.8% and specificity of 88.9% ± 7.6%. Based on the AUC(Area Under a Curve), the diagnostic accuracy of the device in discriminating benign and malignant lesion was high i.e. 87.8% with 95% Confidence Interval (CI) range from 82.1% to 92.1%. These findings proved that the mechanical imaging capability for real-time characterization and differentiation of benign as well as malignant breast lesions. It has the potential to be positioned as an adjunct to mammography and utilized as a screening device for breast cancer detection. However, the study did not mention the type or brand of BMI used as the study tool. 5

10 5.2 Safety There was no evidence retrieved on the safety of SureTouch device or its similar Palpation/Tactile imaging. However, SureTouch is classified under Device Class 2 by US FDA and is only in the US FDA Device Listing Database with no retrievable evidence on the FDA approval. 12,13 The medical device is also given risk class as defined by the manufacturer IIa and received CE mark Cost-effectiveness There was only one simple narrative review that looked into the cost-effectiveness of TI. Detection efficacy and affordability are critical factors that need to be considered. TI had shown higher sensitivity rate than CBE. It may also be performed by qualified personnel who may not necessarily be a physician. Clinical results also indicated that TI screening may substantially decrease benign biopsy rate. In their paper on cost-effectiveness screening for Breast Cancer worldwide, A. Sarvazyan et.al calculated the costeffectiveness of TI for developing countries. 15 For example, the cost-effectiveness of biennial CBE is evaluated as USD522 per life-year saved in India. Taking TI cancer sensitivity at 92%, which is 62% higher than CBE, results in proportional improvement in cost-effectiveness of TI. In fact, the TI examination may be performed by a nurse or qualified technician, rather than a physician, which may additionally improve the costeffectiveness. As a result, the cost effectiveness of TI is USD162 (in prices of 2001), which is over ten times more cost-effective than film mammography. TI screening may also substantially decrease the benign biopsy rate. Thus, TI is a modality that has the potential to provide cost-effectiveness breast cancer screening and diagnosis. 5.4 Training A physician or any other trained healthcare professional can use SureTouch to screen for breast cancer during routine examination. 7 In other words, one needs to be trained prior to the use of the medical device. SureTouch is not a diagnostic product but it enhances the clinical work by providing CBE findings in a reproducible format. The formatted report can be reviewed by the attending medical practitioner, mammographer and breast surgeon. Though it is not mentioned in the relevant website, it is assumed that interpretation of the findings need have some form of training as well. 6. CONCLUSION Based on the above review, there were very limited quality evidences to support the effectiveness and cost-effectiveness of Palpation/Tactile Imaging. There was none on its safety aspect apart from the U.S. FDA listing and CE Mark. The grades of the scientific evidences were mainly of low level (USPSTF Evidence Grading System). The technology had documented clinical findings efficiently with reasonable sensitivity, specificity and PPV. Real time characterization and differentiation between benign and malignant breast lesions were demonstrated with this technology. It had the potential to be a cost-effective screening device for breast cancer and improved the communication between health care providers. 6

11 7. RECOMMENDATION More scientific evidences are required to support the effectiveness, safety and costeffectiveness of SureTouch and its similar technology for use in the screening of Breast Cancer. However, it can be recommended as a research tool in the screening of the above-mentioned clinical condition. 7

12 8. REFERENCES 1. Cancer. Retrieved from on 10 July Breast Cancer. Retrieved from on 10 July 2008 Screening for Breast Cancer. Retrieved from on 11 July Breast Cancer Screening Modalities. Retrieved from on 11 July Screening for Breast Cancer U.S. Preventive Services Task Force. Retrieved from on 14 July SureTouch Pre Mammogram. Retrieved from on 15 July SureTouch Visual Mapping System Electronically Documents The Clinical Breast Exam. Retrieved from on 15 July Kearney TJ, Airaoetian S, Sarvazyan A et al. Tactile breast imaging to increase the sensitivity of breast examination. Journal of Clinical Oncology 2004; Vol. 22 No. 14S: Wellman PS, Dalton EP, Krag D et al. Tactile Imaging of Breast Masses First Clinical Report. ARCH SURG FEB 2001; VOL 136: Kaufman CS, Jacobson L, Bachman BA et al. Digital documentation of the physical examination: moving the clinical breast exam to the electronic medical record. Am J Surg 2006 Oct; 192(4): Egorov V, Kearney T, Pollak SB et al. Differentiation of Benign and Malignant Breast Lesions by Mechanical Imaging. Retrieved from on 15 July U.S. Food and Drug Administration Device Listing database. Document submitted by ZARICH MEDIC Sdn. Bhd. 8

13 13. U.S. Food and Drug Administration at on 23 July Certificate of Conformity with European Directive. Document submitted by ZARICH MEDIC Sdn. Bhd. 15. A. Sarvazyan, V.Egorov, JS Son et al. Cost-effective Screening for Breast Cancer Worldwide: Current State and Future Directions. Retrieved from on 15 July

14 1. APPENDICES 9.1 Appendix 1 - Level of Evidence Table Level I II-1 II-2 II-3 III Study design Evidence obtained from at least one properly designed randomized controlled trial Evidence obtained from well-designed controlled trials without randomization Evidence obtained from well-designed cohort or case-control analytic studies, preferably from more than one centre or research group Evidence obtained from multiple time series with or without the intervention. Dramatic results in uncontrolled experiments (such as the results of the introduction of penicillin treatment in the 1940s) could also be regarded as this type of evidence Opinions or respected authorities, based on clinical experience; descriptive studies and case reports; or reports of expert committees Source: US/CANADIAN PREVENTIVE SERVICES TASK FORCE (HARRIS 2001) 9.2 Appendix 2 - Abbreviations CBE Clinical Breast Examination PI Palpation Imaging TI Tactile Imaging USPSTF U.S. Preventive Services Task Force 2D 2 Dimensional 3D 3 Dimensional FDA Food and Drug Administration USD U.S. Dollar 10

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