Journal
ANNALS OF SURGICAL ONCOLOGY
Volume 22, Issue 10, Pages 3356-3362Publisher
SPRINGER
DOI: 10.1245/s10434-015-4665-2
Keywords
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Funding
- U.S. National Cancer Institute [R44CA165436]
- US National Cancer Institute - Diagnostic Photonics, Inc.
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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. 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. 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. Intraoperative optical imaging of specimen margins with a handheld probe potentially eliminates the majority of reoperations.
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