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
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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.
KeywordsOptical Coherence Tomography Positive Margin Invasive Lobular Carcinoma Margin Assessment Final Margin
This research was funded by the U.S. National Cancer Institute (R44CA165436). We acknowledge Dr. Daniel McCormick for technical contributions and Drs. Robert Buras, Melissa Camp, Mehran Habibi, Clarissa Hammer, Julie Lange, and Wen Liang for study participation and recruiting. This study was funded by the US National Cancer Institute and sponsored by Diagnostic Photonics, Inc. AMZ and AJC are employees of Diagnostic Photonics, Inc. SAB and PSC are co-founders of Diagnostic Photonics, Inc.
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