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.

Abstract

To compare the sentinel lymph node (SLN) identification proportions using Indocyanine green with the standard radio colloid-blue dye method. 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. 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. 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. Indocyanine green (ICG) fluorescence offers comparable sentinel node identification rate when compared to current standard of radioisotope and blue dye. This study is registered under Clinical Trials Registry-India (CTRI) vide registration no. CTRI/2022/09/045719.