title: A randomized prospective study of lumpectomy margin assessment with use of MarginProbe in patients with nonpalpable breast malignancies.
abstract: BACKGROUND
  The presence of tumor cells at the margins of breast lumpectomy specimens is associated with an increased risk of ipsilateral tumor recurrence. Twenty to 30 % of patients undergoing breast-conserving surgery require second procedures to achieve negative margins. This study evaluated the adjunctive use of the MarginProbe device (Dune Medical Devices Ltd, Caesarea, Israel) in providing real-time intraoperative assessment of lumpectomy margins.
  
  
  METHODS
  This multicenter randomized trial enrolled patients with nonpalpable breast malignancies. The study evaluated MarginProbe use in addition to standard intraoperative methods for margin assessment. After specimen removal and inspection, patients were randomized to device or control arms. In the device arm, MarginProbe was used to examine the main lumpectomy specimens and direct additional excision of positive margins. Intraoperative imaging was used in both arms; no intraoperative pathology assessment was permitted.
  
  
  RESULTS
  In total, 596 patients were enrolled. False-negative rates were 24.8 and 66.1 % and false-positive rates were 53.6 and 16.6 % in the device and control arms, respectively. All positive margins on positive main specimens were resected in 62 % (101 of 163) of cases in the device arm, versus 22 % (33 of 147) in the control arm (p < 0.001). A total of 19.8 % (59 of 298) of patients in the device arm underwent a reexcision procedure compared with 25.8 % (77 of 298) in the control arm (6 % absolute, 23 % relative reduction). The difference in tissue volume removed was not significant.
  
  
  CONCLUSIONS
  Adjunctive use of the MarginProbe device during breast-conserving surgery improved surgeons' ability to identify and resect positive lumpectomy margins in the absence of intraoperative pathology assessment, reducing the number of patients requiring reexcision. MarginProbe may aid performance of breast-conserving surgery by reducing the burden of reexcision procedures for patients and the health care system.
authors.affiliation: Department of Surgery, NYU Langone Medical Center, NYU Clinical Cancer Center, New York, NY, USA, freya.schnabel@nyumc.org.
authors.forename: Freya
authors.initials: F
authors.lastname: Schnabel
authors.forename: Susan K
authors.initials: SK
authors.lastname: Boolbol
authors.forename: Mark
authors.initials: M
authors.lastname: Gittleman
authors.forename: Tami
authors.initials: T
authors.lastname: Karni
authors.forename: Lorraine
authors.initials: L
authors.lastname: Tafra
authors.forename: Sheldon
authors.initials: S
authors.lastname: Feldman
authors.forename: Alice
authors.initials: A
authors.lastname: Police
authors.forename: Neil B
authors.initials: NB
authors.lastname: Friedman
authors.forename: Scott
authors.initials: S
authors.lastname: Karlan
authors.forename: Dennis
authors.initials: D
authors.lastname: Holmes
authors.forename: Shawna C
authors.initials: SC
authors.lastname: Willey
authors.forename: Moshe
authors.initials: M
authors.lastname: Carmon
authors.forename: Kristen
authors.initials: K
authors.lastname: Fernandez
authors.forename: Stephanie
authors.initials: S
authors.lastname: Akbari
authors.forename: Jay
authors.initials: J
authors.lastname: Harness
authors.forename: Lisa
authors.initials: L
authors.lastname: Guerra
authors.forename: Thomas
authors.initials: T
authors.lastname: Frazier
authors.forename: Karen
authors.initials: K
authors.lastname: Lane
authors.forename: Rache M
authors.initials: RM
authors.lastname: Simmons
authors.forename: Alison
authors.initials: A
authors.lastname: Estabrook
authors.forename: Tanir
authors.initials: T
authors.lastname: Allweis
mesh_terms: D001943:Breast Neoplasms / Q000473:pathology* / Q000601:surgery*; D018270:Carcinoma, Ductal, Breast / Q000473:pathology / Q000601:surgery; D002285:Carcinoma, Intraductal, Noninfiltrating / Q000473:pathology / Q000601:surgery; D018275:Carcinoma, Lobular / Q000473:pathology / Q000601:surgery; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007430:Intraoperative Care / Q000295:instrumentation*; D015412:Mastectomy, Segmental / Q000295:instrumentation*; D008875:Middle Aged; D009361:Neoplasm Invasiveness; D009367:Neoplasm Staging; D018365:Neoplasm, Residual / Q000517:prevention & control; D011379:Prognosis; D011446:Prospective Studies