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This research aims to evaluate the effectiveness of a new NIR-II fluorescence imaging platform in tumor margin assessment during breast surgery.

July 2, 2026Open Access

Intraoperative NIR-II fluorescence guidance for precise tumor margin assessment and maximized tissue preservation in breast surgery

YZYiyin ZhangPeking University KLKe LiBeijing University of Posts and Telecommunications SZShuwei ZhangPeking University

Key Points

This research aims to evaluate the effectiveness of a new NIR-II fluorescence imaging platform in tumor margin assessment during breast surgery.
Developed a NIR-II fluorescence navigation platform utilizing indocyanine green (ICG).
Conducted a study with 37 patients administered 1 mg/kg ICG prior to surgery.
Assessed imaging quality using PIQE score and analyzed tumor contrast through TNR and SBR metrics.
NIR-II imaging showed a higher tumor-to-normal tissue ratio of 4.383 ± 1.719 compared to 3.154 ± 1.072 (P < 0.0001).
Demonstrated greater tumor detection sensitivity at 90.63% versus 84.38%, achieving 100% diagnostic accuracy for malignant margins.
Ex vivo imaging indicated potential for reduced excision volume compared to standard methods.

Abstract

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.

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