BACKGROUND: Accurate margin assessment remains a challenge in breast-conserving surgery, where inaccuracy leads to excessive removal and compromised aesthetics. Although second near-infrared (NIR-II) fluorescence imaging offers high contrast, there is still a lack of clinically viable NIR-II equipment. METHODS: We develop an innovative NIR-II fluorescence navigation platform based on indocyanine green (ICG) that enables rapid deployment, operation-friendly workflow, and precision-at-hand capability for intraoperative guidance. Thirty-seven patients were recruited with 1 mg/kg ICG injection 45 minutes before surgery. Image quality was evaluated using perception-based image quality evaluator (PIQE) score, while quantitative analyses of fluorescence, including tumor-to-normal tissue ratio (TNR) and signal-to-background ratio (SBR), together with histopathology and a multi-level reader study, were performed to assess tumor contrast and diagnostic performance. RESULTS: Compared to conventional NIR-I imaging, our NIR-II system demonstrates performance with enhanced spatial resolution and a higher tumor-to-normal tissue ratio (4.383 ± 1.719 versus 3.154 ± 1.072, P < 0.0001) in 37 patients. The intraoperative NIR-II imaging demonstrates superior tumor detection sensitivity 90.63% (75.78%-96.76%) vs. 84.38% (68.25%-93.14%), with 100% diagnostic accuracy in delineating malignant tumor margins. Ex vivo NIR-II imaging enables real-time, precise visualization of tumor margins and suggested its potential to reduce the volume of excision. (NIR-II-defined volume < NIR-I-defined volume < current resection volume). Through brief training, surgeons can effectively utilize NIR-II imaging, shortening the learning curve for young surgeons in tumor and margin assessment. CONCLUSION: This study demonstrates a clinically adaptable NIR-II imaging platform that expands intraoperative visualization without changing surgical workflow or adding operational burden, supporting standardized margin assessment and improved tissue preservation in breast surgery.
Zhang et al. (Mon,) studied this question.