Evaluating Single Agent Indocyanine Green as an Alternative to Dual Dye-Tracer Mapping in Sentinel Lymph Node Biopsy for Breast Cancer: A Two-Arm Open-Label Randomized Controlled Trial.

[AIM] To compare the sentinel lymph node (SLN) identification proportions using Indocyanine green with the standard radio colloid-blue dye method.

[BACKGROUND] Radioisotope and blue dye are standard agents for performing sentinel lymph node (SLN) biopsy in breast cancer. Limited centers offering nuclear medicine services along with the short half-life of technetium and the hazards associated with radioactive materials contribute to the low acceptability of SLNB.

[METHODS] This randomized controlled trial conducted between September 2022 and May 2024 compared SLN identification proportions of radioisotope-blue dye [Group A] with Indocyanine Green (ICG) [Group B]. Sample size of 70 (35 in each arm) was calculated. Upfront operable node negative early breast cancer patients were included in the study. Clinico-demographic data, number and type of SLN, and time taken were recorded. Chi-squared/Fisher exact tests were used to compare proportions between two groups. p value of less than 0.05 was considered to represent statistical significance.

[RESULTS] Seventy patients were randomized to either group (35 in Group A and 35 in group B). The clinico-demographics and the tumor characteristics were similar between both the groups. SLN identification rate (IR) was 100% in group A and 97.14% in group B. Median of 3 lymph nodes were identified in Group A and Group B. Median operative time for SLNB was 12 min in both the groups.

[CONCLUSIONS] Indocyanine green (ICG) fluorescence offers comparable sentinel node identification rate when compared to current standard of radioisotope and blue dye.

[TRIAL REGISTRATION] This study is registered under Clinical Trials Registry-India (CTRI) vide registration no. CTRI/2022/09/045719.