title: Intra-operative assessment of excised breast tumour margins using ClearEdge imaging device.
abstract: BACKGROUND
  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%.
  
  
  CONCLUSIONS
  This study shows that the CE device has potential to reduce re-excision after BCS and further randomized studies of its value are warranted.
authors: Edinburgh Breast Unit, Western General Hospital, Edinburgh, Scotland, UK; University of Edinburgh, Medical School, Scotland, UK. Electronic address: mike.dixon@ed.ac.uk.
authors: J M
authors: JM
authors: Dixon
authors: Edinburgh Breast Unit, Western General Hospital, Edinburgh, Scotland, UK.
authors: L
authors: L
authors: Renshaw
authors: Edinburgh Breast Unit, Western General Hospital, Edinburgh, Scotland, UK.
authors: O
authors: O
authors: Young
authors: Edinburgh Breast Unit, Western General Hospital, Edinburgh, Scotland, UK.
authors: D
authors: D
authors: Kulkarni
authors: Edinburgh Breast Unit, Western General Hospital, Edinburgh, Scotland, UK.
authors: T
authors: T
authors: Saleem
authors: LS BioPath, Mountain View, CA, USA.
authors: M
authors: M
authors: Sarfaty
authors: LS BioPath, Mountain View, CA, USA.
authors: R
authors: R
authors: Sreenivasan
authors: LS BioPath, Mountain View, CA, USA.
authors: C
authors: C
authors: Kusnick
authors: Pathology Department, Western General Hospital, Edinburgh, Scotland, UK.
authors: J
authors: J
authors: Thomas
authors: University of Edinburgh, Medical School, Scotland, UK.
authors: L J
authors: LJ
authors: Williams
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001943:Breast Neoplasms / Q000000981:diagnostic imaging* / Q000601:surgery; D018270:Carcinoma, Ductal, Breast / Q000150:complications / Q000000981:diagnostic imaging* / Q000601:surgery; D002285:Carcinoma, Intraductal, Noninfiltrating / Q000150:complications / Q000000981:diagnostic imaging* / Q000601:surgery; D018275:Carcinoma, Lobular / Q000000981:diagnostic imaging* / Q000601:surgery; D058266:Dielectric Spectroscopy / Q000295:instrumentation / Q000379:methods*; D005260:Female; D006801:Humans; D007432:Intraoperative Period; D008297:Male; D000072662:Margins of Excision; D015412:Mastectomy, Segmental; D008875:Middle Aged; D018365:Neoplasm, Residual; D011237:Predictive Value of Tests
keywords: Breast cancer; Intra-operative margin assessment; Re-excision