title: Intraoperative Assessment of Final Margins with a Handheld Optical Imaging Probe During Breast-Conserving Surgery May Reduce the Reoperation Rate: Results of a Multicenter Study.
abstract: BACKGROUND
  A multicenter, prospective, blinded study was performed to test the feasibility of using a handheld optical imaging probe for the intraoperative assessment of final surgical margins during breast-conserving surgery (BCS) and to determine the potential impact on patient outcomes.
  
  
  METHODS
  Forty-six patients with early-stage breast cancer (one with bilateral disease) undergoing BCS at two study sites, the Johns Hopkins Hospital and Anne Arundel Medical Center, were enrolled in this study. During BCS, cavity-shaved margins were obtained and the final margins were examined ex vivo in the operating room with a probe incorporating optical coherence tomography (OCT) hardware and interferometric synthetic aperture microscopy (ISAM) image processing. Images were interpreted after BCS by three physicians blinded to final pathology-reported margin status. Individual and combined interpretations were assessed. Results were compared to conventional postoperative histopathology.
  
  
  RESULTS
  A total of 2,191 images were collected and interpreted from 229 shave margin specimens. Of the eight patients (17 %) with positive margins (0 mm), which included invasive and in situ diseases, the device identified all positive margins in five (63%) of them; reoperation could potentially have been avoided in these patients. Among patients with pathologically negative margins (>0 mm), an estimated mean additional tissue volume of 10.7 ml (approximately 1% of overall breast volume) would have been unnecessarily removed due to false positives.
  
  
  CONCLUSIONS
  Intraoperative optical imaging of specimen margins with a handheld probe potentially eliminates the majority of reoperations.
authors.affiliation: Diagnostic Photonics, Inc., Chicago, IL, USA.
authors.forename: Adam M
authors.initials: AM
authors.lastname: Zysk
authors.forename: Kai
authors.initials: K
authors.lastname: Chen
authors.forename: Edward
authors.initials: E
authors.lastname: Gabrielson
authors.forename: Lorraine
authors.initials: L
authors.lastname: Tafra
authors.forename: Evelyn A
authors.initials: EA
authors.lastname: May Gonzalez
authors.forename: Joseph K
authors.initials: JK
authors.lastname: Canner
authors.forename: Eric B
authors.initials: EB
authors.lastname: Schneider
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Cittadine
authors.forename: P
authors.initials: P
authors.lastname: Scott Carney
authors.forename: Stephen A
authors.initials: SA
authors.lastname: Boppart
authors.forename: Kimiko
authors.initials: K
authors.lastname: Tsuchiya
authors.forename: Kristen
authors.initials: K
authors.lastname: Sawyer
authors.forename: Lisa K
authors.initials: LK
authors.lastname: Jacobs
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001943:Breast Neoplasms / Q000473:pathology / Q000601:surgery*; D018270:Carcinoma, Ductal, Breast / Q000473:pathology / Q000601:surgery*; D018275:Carcinoma, Lobular / Q000473:pathology / Q000601:surgery*; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007432:Intraoperative Period; D015412:Mastectomy, Segmental; D008866:Microsurgery; D008875:Middle Aged; D009361:Neoplasm Invasiveness; D009367:Neoplasm Staging; D011379:Prognosis; D011446:Prospective Studies; D012086:Reoperation / Q000706:statistics & numerical data*; D041623:Tomography, Optical Coherence / Q000379:methods*