A Randomized Prospective Non-Inferiority Trial of Sentinel Lymph Node Biopsy in Early Breast Cancer: Blue Dye Compared with Indocyanine Green Fluorescence Tracer

Abstract

Background: Indocyanine green (ICG) is a promising tracer for sentinel lymph node biopsy in early breast cancer. This randomized study was conducted to evaluate sentinel lymph node biopsy with ICG compared with blue dye as a tracer in woman with early breast cancer without any sign of lymph node invasion. Methods: Between January 2019 and November 2020, 240 consecutive women with early breast cancer were enrolled and randomized to sentinel lymph node biopsy using ICG or blue dye. The primary endpoint was the sentinel lymph node detection rate in both arms. Results: ICG was used in 121 patients and detected sentinel lymph nodes in all patients (detection rate, 100%; 95% CI: 96.9–100.0) while blue dye was used in 119 patients and detected sentinel lymph nodes in 116 patients (detection rate: 97.5%, 95% CI: 92.9–99.1). This analysis indicated the non-inferiority of ICG vs. blue dye tracer (90%CI: −1.9–6.9; p = 0.0009). Conclusion: ICG represents a new promising tracer to detect sentinel lymph nodes in early breast cancer with a detection rate similar to other conventional tracers, and is associated with easy learning and low cost. Our result suggest that this technique is a good alternative to avoid radioactive isotope manipulation.