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INTRODUCTION: Breast conserving surgery (BCS) removes the tumor with a surrounding margin of normal breast tissue, and to reduce local recurrence clear margins are needed. Involved margins identified by pathology several days later require a second operation. Between 20-40% of BCS patients require re-excision. There is a clear unmet clinical need for effective and efficacious intra-operative, real time assessment of breast tumor margins. The handheld, battery operated TOUCH Imaging device displays spatially resolved images of margins based on tissue spectral dielectric response. This novel imaging device enables surgeons to assess in real-time the status of the excised tissue margins. AIM: To determine the efficacy and safety of TOUCH Imaging device as used by surgeons during BCS and its health economics. METHOD: The 1st study of the TOUCH Imaging device was run in the USA with freshly excised breast tissue as part of BCS. The study was run in the pathology lab to determine the efficacy and safety of using the device. The efficacy was determined by surgeons interpretation of device generated margin images compared with permanent section pathology. A follow up study in the UK is currently underway. Surgeons were trained to use the device in the operating room on freshly excised tissue. The imaging was performed after the surgery was completed with no subsequent intervention. The margins were scored as clear or positive and the localization of the abnormality was marked using special ink for specific pathology attention. In the learning phase 18 BCS cases were performed. The main study is being run in two phases and is currently underway. Phase-1 aimed to determine the accuracy of the device when used by individual surgeons in real time had been completed. Analysis is on the way, and phase-2 will start following the confirmation of device accuracy and will involve using the device to direct intra-operatively which margins require further excision. Phase 2 will provide insight to the potential health economics of using the TOUCH Imaging device. RESULTS: Data from the first study in the USA on 50 BCS specimens, imaging 214 distinct margins are shown in the table. The sensitivity of the device is high; the false negative rate low, the specificity and false positive rates are satisfactory. TOUCH Compared to Permanent Section Pathology Positive PathologyNegative PathologyPositive TOUCH66 ( 30.8%)50 (23.4%))Negative TOUCH5 ( 2.3%)93 ( 43.5%) % (95% CI)% (90% CI)Sensitivity92.96 (84.33, 97.67)92.96 ( 85.76, 97.18)Specificity65.03 (56.62, 72.81)65.03 (57.93, 71.66)False Positive Rate34.97 ( 27.19, 43.38)34.97 (28.34, 42.07)False negative Rate7.04 ( 2.33, 15.67)7.04 ( 2.82, 14.24) The training study in the UK on 18 BCS specimen results showed 50% True Positive, 39% True Negative, 11% False Positive, 6% False Negative rates. There were 5 cases (28%) of positive margins < 1 mm and the device images identified 4 with 1 case (6%) being missed. Results from the ongoing study will be presented. CONCLUSIONS: • The TOUCH Imaging device is safe and efficacious. • It is easy for surgeons to use in the operating room. • This device has the potential to reduce BCS re-operation rate. Citation Format: J Michael Dixon, Lorna Renshaw, Oliver Young, Dhananjay Kulkarni, Talha Saleem, Moshe Sarfaty, Ramaswamy Sreenivasam, Catherine Kusnick, Jeremy Thomas. Intra-operative imaging of surgical margins in breast conserving surgery using localized tissue dielectric response [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P1-16-05.

Introduction Breast conserving surgery (BCS) aims to remove a breast cancer completely and obtain clear margins. Complete excision is essential to reduce the risk of local recurrence. The ClearEdge™ (CE) imaging device examines margins of excised breast tissue intra-operatively. The aim of this study was to investigate the potential of the device in detecting margin involvement in patients having BCS. Methods In Phase-1 58 patients underwent BCS and had 334 margins assessed by the device. In Phase-2 the device was used in 63 patients having BCS and 335 margins were assessed. Patients with margins considered close or involved by the CE device were re-excised. Results The margin assessment accuracies in Phase-1 and Phase-2 compared to permanent section pathology were very similar: sensitivity (84.3% and 87.3%), specificity (81.9% and 75.6%), positive predictive value (67.2% and 63.6%), and negative predictive value (92.2% and 92.4%). The false positive rate (18.1% and 24.4%) and false negative rate (15.7% and 12.7%) were low in both phases. In Phase-2 re-excision rate was 37%, but in the 54 where the CE device was used appropriately the re-excision rate was 17%. Had all surgeons interpreted all images appropriately and re-excised margins detected as abnormal by the device in Phase-2 then the re-excision rate would have been 7%. Conclusion This study shows that the CE device has potential to reduce re-excision after BCS and further randomized studies of its value are warranted.

Background: Axillary management in breast cancer is evolving. Recent ACSO guidelines have suggested that axillary node clearances (ANC) are not necessary in the positive axilla in early breast cancers with small nodal burdens, undergoing breast conserving surgery (BCT). According to ASCO guidelines, G1-2, T1-2 tumours with 1 or 2 SLN macrometastases, undergoing BCT should not undergo ANC. We compare current practice in a screening population against these guidelines. Methods: We retrospectively analysed all patients with invasive breast cancer under the regional screening programme (2011e2014), looking specifically at management of patients who would not be offered ANC under ASCO guidelines. Results: 687 screening patients were diagnosed in the time frame. 516 had normal axillary USS and 143 e abnormal. Of the 516 normal USS, 79 (15.3%) had malignant sentinel lymph nodes (SLNB), (45 (57%) were macrometastases of which, 93% had 1e2 positive nodes. 34 (43%) were micrometastases). 86 abnormal USS had SLNB, 16 of which were malignant, 12 macrometastases (100% 1e2 positive nodes). 36 of the malignantmacrometastatic SLNBmet ASCO guidelines. 24 of those received ANC (67%), 7 (30%) of which were positive, 2 with heavy nodal burdens (10/14 and 5/20). The remainder had 1 positive node. Conclusion: Under updated ASCO guidance on SLNB in early breast cancer, we are over-treating the majority of screening patients. However, had these guidelines been followed, 19% of our patients would have had a missed diagnosis of further axillary disease, and in 5% a significant nodal burden would have remained undetected. As clinicians, there is a responsibility to balance and articulate that trade off when discussing axillary management with patients.

In 2009, Aetna, Inc., invited Gary Kraftsow and the American Viniyoga Institute (AVI) to contribute to a research study on modulating stress. This partnership represented the first formal recognition of the potential role of yoga therapy in modern healthcare by an insurance company. This project exemplified the power and value of a collaboration in which yoga therapists made the ancient yoga teachings relevant to healthcare research. We must under-stand our own ancient traditions, learn the language of Western medicine, and recognize opportunities to build bridges to medical disciplines, academic partners, insurers, funders, and policy makers.