Quantitative micro-elastography (QME) is a compression-based optical coherence elastography technique that visualizes micro-scale tissue stiffness. Current benchtop QME shows great potential for identifying cancer in excised breast tissue (96% diagnostic accuracy), but cannot image cancer directly in the patients. We present the development of a handheld QME probe to directly image the surgical cavity in vivo during breast-conserving surgery (BCS) and a preliminary clinical demonstration. The results from 21 patients indicate that in vivo QME can identify residual cancer based on the elevated stiffness by directly imaging the surgical cavity, potentially contributing to a more complete cancer excision during BCS.
Re-excision following breast-conserving surgery (BCS) due to suspected residual cancer left from the primary surgery causes substantial physical, psychological, and financial burdens for patients. This study provides a first-in-human clinical study of in vivo quantitative micro-elastography (QME) for in-cavity identification of residual cancer. A custom-built handheld QME probe is used to directly scan the surgical cavity for imaging the micro-scale tissue stiffness during BCS. In vivo QME of 21 patients, validated by co-registered histopathology of the excised specimens, demonstrates the capability to detect residual cancer based on its elevated micro-scale stiffness, potentially contributing to a more complete cancer removal.
Breast-conserving surgery (BCS) for treatment of breast cancer requires complete removal of the tumor. 20-30% of patients undergoing BCS require multiple surgeries due to cancer at or near the boundary (margin) of the excised tissue as assessed by postoperative histopathology. Intraoperative detection of involved margins could significantly reduce the number of patients requiring repeat surgeries. We built and deployed a portable optical coherence elastography system capable of rapid, 3D imaging of whole margins (46x46 mm) of excised breast specimens (wide local excisions, WLEs) removed during BCS. The system produces images of the microstructure and stiffness of the tissue using a phase-sensitive, compression-based elastography approach. The goal of this study was to determine the diagnostic accuracy (sensitivity and specificity), using this system, of OCT versus OCT plus micro-elastography for detecting cancer within 0.75 mm of the margin of the excised tissue. >70 women undergoing BCS were enrolled in the study. We scanned two margins from each fresh, intact surgical specimen within 2 hours of excision. We selected 10x10x0.75mm regions of interest (ROIs) from each margin scanned that are representative of the makeup of breast tissue. Post-operative histology, co-registered with the scans, was used as a gold standard, and a pathologist determined the tissue types present within each ROI based on corresponding histology. Recruitment for the study is complete, and a blinded reader analysis of one ROI from each margin is being performed by two surgeons, a pathologist, a radiologist, and an engineer. Results for sensitivity and specificity will be presented.
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