title: An intraoperative MRI system for margin assessment in breast conserving surgery: Initial results from a novel technique.
abstract: OBJECTIVE
  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. © 2016 Wiley Periodicals, Inc.
authors.affiliation: Assuta Medical Center, Tel-Aviv, Israel.|Sackler School of Medicine, Tel Aviv University, Tel-Aviv, Israel.
authors.forename: Moshe
authors.initials: M
authors.lastname: Papa
authors.affiliation: Breast Health Center, Kaplan Medical Center, Rehovot, Israel.
authors.forename: Tanir
authors.initials: T
authors.lastname: Allweis
authors.affiliation: Sackler School of Medicine, Tel Aviv University, Tel-Aviv, Israel.|Breast Care Institute, Assaf Harofeh Medical Center, Zrifin, Israel.
authors.forename: Tami
authors.initials: T
authors.lastname: Karni
authors.affiliation: Sackler School of Medicine, Tel Aviv University, Tel-Aviv, Israel.|Department of Pathology, Assaf Harofeh Medical Center, Zrifin, Israel.
authors.forename: Judith
authors.initials: J
authors.lastname: Sandbank
authors.affiliation: LEM Labs, Rehovot, Israel.
authors.forename: Myriam
authors.initials: M
authors.lastname: Konichezky
authors.affiliation: Department of Pathology, Kaplan Medical Center, Rehovot, Israel.
authors.forename: Judith
authors.initials: J
authors.lastname: Diment
authors.affiliation: Clear-Cut Medical Ltd., Rehovot, Israel.
authors.forename: Assaf
authors.initials: A
authors.lastname: Guterman
authors.affiliation: Clear-Cut Medical Ltd., Rehovot, Israel.
authors.forename: Moshe
authors.initials: M
authors.lastname: Shapiro
authors.affiliation: Clear-Cut Medical Ltd., Rehovot, Israel.
authors.forename: Zachi
authors.initials: Z
authors.lastname: Peles
authors.affiliation: Clear-Cut Medical Ltd., Rehovot, Israel.
authors.forename: Roi
authors.initials: R
authors.lastname: Maishar
authors.affiliation: Clear-Cut Medical Ltd., Rehovot, Israel.
authors.forename: Assaf
authors.initials: A
authors.lastname: Gur
authors.affiliation: Clear-Cut Medical Ltd., Rehovot, Israel.
authors.forename: Eyal
authors.initials: E
authors.lastname: Kolka
authors.affiliation: Department of Radiology, The George Washington University, Washington DC.
authors.forename: Rachel
authors.initials: R
authors.lastname: Brem
mesh_terms: D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000000981:diagnostic imaging* / Q000473:pathology / Q000601:surgery*; D005260:Female; D006801:Humans; D007432:Intraoperative Period; D008279:Magnetic Resonance Imaging / Q000295:instrumentation / Q000379:methods; D000072662:Margins of Excision; D015412:Mastectomy, Segmental / Q000379:methods*; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D012372:ROC Curve; D012680:Sensitivity and Specificity
keywords: breast cancer; breast conserving surgery; intraoperative MRI; intraoperative margin assessment; lumpectomy; surgical margins