Background:Although radioisotope (RI) combined with blue dye (BD) is the standard technique for sentinel lymph node (SLN) biopsy in breast cancer, the use of RI is limited at some institutions due to the specific equipment needed. Indocyanine green (ICG) fluorescence detection has been developed as a potential substitute for RI method. However, reports on the sensitivity of ICG and RI techniques in detecting SLN are inconsistent; hence, the present study was designed to compare the clinical efficacy between the combined method of ICG + BD (ICG-B) and RI + BD (RI-B).Methods:A prospective observational study was performed that identified 138 breast cancer patients who had undergone lymphatic mapping and SLN biopsy with ICG-B or RI-B. The SLN detection rate, positive SLN counts, and lymph node metastasis between the 2 groups were compared.Results:A total of 71 patients were recruited in the ICG-B group, while 67 were recruited in the RI-B group. The SLN detection rate was 100% in both the ICG-B and RI-B groups. Lymph node metastasis was found in 13 patients using ICG-B and in 12 patients using the RI-B technique (18.31% vs 17.91%, respectively; P = .61). No significant differences were observed in the positive SLN counts (3.12 +/- 2.01 vs 3.33 +/- 2.24, P = .37) between the 2 groups.Conclusions:Indocyanine green combined with BD has an equal efficacy compared with RI plus BD when performing an axillary SLN biopsy in breast cancer. The ICG plus BD procedure is a promising alternative to traditional standard mapping methods.