Can Low-cost Indo Cyanine Green Florescence Technique for Sentinel Lymph Node Biopsy Replace Dual Dye (Radio-colloid and Blue Dye) Technique in Early Breast Cancer: A Prospective Two-arm Comparative Study

The objective of this study was to assess the detection and accuracy of sentinel lymph node (SLN) biopsy (SLNB) using the low-cost indocyanine green (ICG) fluorescence method and to compare this method with the gold standard dual-dye method (radio-colloid + methylene blue dye [MB]). One hundred patients with node-negative early breast cancer assessed clinically and by ultrasound axilla underwent an SLNB procedure using technetium-99m radio-colloid, MB, and ICG. The detection rate of SLNs and positive SLNs and the number of SLNs were compared. The injection safety of ICG and MB was evaluated. One hundred female patients with a median age of 52.3 years participated in the study. Sixty-eight percent had a body mass index < 25, 85% presented with a palpable lump, of which 59% were in the outer quadrant. SLNs were identified in all 100 cases. A total of 290 SLNs were removed (mean, 2.9; range, 1-6). The identification rate with dual dye was 94%, whereas with ICG alone, it was 96%. The SLNB sensitivity rate and false negative rate were 97.6% versus 93.2% and 3.1% versus 6.2% in the ICG and dual-dye combination, respectively. None of the patients had any local or systemic reaction with ICG; 3 patients with blue dye had tattooing and staining of skin. ICG fluorescence imaging permits real time visualization of lymphatics and provides an additional dimension to SLN biopsy that is safe and effective. These results confirm high sensitivity for fluorescence localization with comparable performance to the gold standard. ICG can reliably replace dual dye and be employed as a sole tracer for SLNB in early breast cancer. This non-randomized, prospective, observational study was conducted to assess the detection and accuracy of sentinel lymph node detection with indocyanine green in comparison with the gold standard dual-dye technique. The study confirms high sensitivity for fluorescence localization with comparable performance with the gold standard. Indocyanine green can be employed as a sole tracer avoiding potential drawbacks of standard tracer agents.