A Novel Color Fluorescence Navigation System for Intraoperative Transcutaneous Lymphatic Mapping and Resection of Sentinel Lymph Nodes in Breast Cancer: Comparison with the Combination of Gamma Probe Scanning and Visible Dye Methods.

BACKGROUND: This study evaluated the clinical efficacy of a novel imaging system (HyperEye Medical System [HEMS]; Mizuho Corp., Tokyo, Japan) that uses the near-infrared (NIR) fluorescence of indocyanine green to analyze sentinel lymph node (SLN) biopsies for the staging of breast cancer.

METHODS: This study enrolled 91 patients with histologically confirmed breast cancer that was clinically node negative with a tumor size <3 cm. We compared SLN identification rates between HEMS and conventional methods (gamma probe scanning using a colloidal radioisotope [RI] and a blue dye method) by analyzing the relationships of lymphatic to axillary lesions and SLNs.

RESULTS: The identification rate of SLNs was 100% using HEMS, 97.8% using the RI method, and 95.6% using the blue dye method. Two types of lymphatic pathway (LP) were detected in 39 patients (42.9%) and also clearly identified using HEMS-captured color and NIR fluorescence. The incidence of two or more SLNs was significantly higher in patients with a two-route LP to the axilla group than in those with only one route (p < 0.001; 43.6 vs. 9.6%).

CONCLUSIONS: The HEMS NIR fluorescence color imaging method is a promising potential modality for higher-level identification of SLNs than a standard combination of the RI and blue dye methods.