Moshe Papa1,2, Tanir Allweis3, Tami Karni2,4, Judith Sandbank2,5, Myriam Konichezky6, Judith Diment7, Assaf Guterman8, Moshe Shapiro8, Zachi Peles8, Roi Maishar8, Assaf Gur8, Eyal Kolka8, Rachel Brem9. 1. Assuta Medical Center, Tel-Aviv, Israel. 2. Sackler School of Medicine, Tel Aviv University, Tel-Aviv, Israel. 3. Breast Health Center, Kaplan Medical Center, Rehovot, Israel. 4. Breast Care Institute, Assaf Harofeh Medical Center, Zrifin, Israel. 5. Department of Pathology, Assaf Harofeh Medical Center, Zrifin, Israel. 6. LEM Labs, Rehovot, Israel. 7. Department of Pathology, Kaplan Medical Center, Rehovot, Israel. 8. Clear-Cut Medical Ltd., Rehovot, Israel. 9. Department of Radiology, The George Washington University, Washington DC.
Abstract
BACKGROUND AND OBJECTIVES: One of the major unmet needs in Breast Conserving Surgery (BCS) is a rapid and accurate margin assessment of the lumpectomy specimen. This study evaluates the ability of a novel MRI system (prototype of the ClearSight™ system; Clear-Cut Medical Ltd., Rehovot, Israel) to distinguish malignant and non-malignant tissues in freshly excised breast specimen by comparing MR measurements to histopathology results. METHODS: Seventy-seven samples were obtained from 22 patients undergoing BCS enrolled in the study. A T2* (T2 Star) value in milliseconds (ms) was calculated for each sample and correlated with histopathology results. RESULTS: Of the 77 samples, 35 samples were classified by histopathology as malignant and 42 as non-malignant. T2* values were significantly higher in malignant samples compared to non-malignant samples (15.3 ± 2.72 ms and 10.6 ± 1.47 ms, respectively [P < 0.00001]). Analysis for a determined cutoff of 11.7 ms revealed 91% sensitivity, 93% specificity, and 92% accuracy. ROC curve analysis yielded AUC of 0.97. CONCLUSIONS: This study demonstrates that the system is sensitive and specific in differentiating malignant and non-malignant tissues in freshly excised breast specimen. The system has the potential to be used for breast specimen margin assessment during BCS, with the goal of decreasing the need for re-operation. J. Surg. Oncol. 2016;114:22-26.
BACKGROUND AND OBJECTIVES: One of the major unmet needs in Breast Conserving Surgery (BCS) is a rapid and accurate margin assessment of the lumpectomy specimen. This study evaluates the ability of a novel MRI system (prototype of the ClearSight™ system; Clear-Cut Medical Ltd., Rehovot, Israel) to distinguish malignant and non-malignant tissues in freshly excised breast specimen by comparing MR measurements to histopathology results. METHODS: Seventy-seven samples were obtained from 22 patients undergoing BCS enrolled in the study. A T2* (T2 Star) value in milliseconds (ms) was calculated for each sample and correlated with histopathology results. RESULTS: Of the 77 samples, 35 samples were classified by histopathology as malignant and 42 as non-malignant. T2* values were significantly higher in malignant samples compared to non-malignant samples (15.3 ± 2.72 ms and 10.6 ± 1.47 ms, respectively [P < 0.00001]). Analysis for a determined cutoff of 11.7 ms revealed 91% sensitivity, 93% specificity, and 92% accuracy. ROC curve analysis yielded AUC of 0.97. CONCLUSIONS: This study demonstrates that the system is sensitive and specific in differentiating malignant and non-malignant tissues in freshly excised breast specimen. The system has the potential to be used for breast specimen margin assessment during BCS, with the goal of decreasing the need for re-operation. J. Surg. Oncol. 2016;114:22-26.
Authors: Samuel S Streeter; Benjamin W Maloney; Rebecca A Zuurbier; Wendy A Wells; Richard J Barth; Keith D Paulsen; Brian W Pogue Journal: Phys Med Biol Date: 2021-06-01 Impact factor: 4.174
Authors: Swati A Kulkarni; Kirti Kulkarni; David Schacht; Sonya Bhole; Ingrid Reiser; Hiroyuki Abe; Jean Bao; Kevin Bethke; Nora Hansen; Nora Jaskowiak; Seema A Khan; Jennifer Tseng; Buxin Chen; Jennifer Pincus; Jeffrey Mueller; Lauren Schulte; Bazil LaBomascus; Zheng Zhang; Dan Xia; Xiaochuan Pan; Christian Wietholt; Dimple Modgil; David Lester; Li Lan; Bidur Bohara; Xiao Han Journal: Ann Surg Oncol Date: 2021-07-31 Impact factor: 5.344