A Dose-Image Optimization Trial for Voluven®-Assisted Indocyanine Green Fluorescence-Guided Breast Cancer Sentinel Lymph Node Surgery.

Abstract

Sentinel lymph node biopsy (SLNB) is critical in breast cancer staging, and indocyanine green (ICG) has emerged as a promising fluorescent tracer. Optimizing ICG concentration with an appropriate solvent such as Voluven® could improve imaging quality and SLN detection, yet the ideal protocol remains undefined. This study investigates the optimal ICG:Voluven concentration for SLNB in breast cancer surgery. In a prospective trial (April 2022-June 2023), 12 women with early breast cancer underwent SLNB with ICG:Voluven at 0.5 mg/mL (5×, n = 3), 0.25 mg/mL (10×, n = 6), or 0.125 mg/mL (20×, n = 3). Outcomes included SLN retrieval, signal-to-background ratio (SBR), areola-to-axilla traveling time (AAT), safety, and cost, assessed via Stryker SPY Portable Handheld Imaging System. The 10× group (0.25 mg/mL) showed the highest median SBR (127.4, range 90.9-256.0) versus 5× (26.3, 2.7-133.2) and 20× (39.1, 5.3-98.4), retrieving three SLNs per patient consistently, unlike fewer in other groups. The 20× group had the shortest AAT (44.3 s) but lower SBR and procedural issues (e.g., subcutaneous dissection). The 5× group had the longest AAT (144.3 s) and reduced SLN detection. No adverse events occurred. The equivalent drug cost was around 1.5 US dollars per patient. The 0.25 mg/mL ICG:Voluven concentration offers an optimal balance of fluorescence imaging quality, SLN detection, and procedural efficiency for SLNB in breast cancer surgery. Its safety, effectiveness, and low cost make it a practical choice, especially in resource-limited settings. Larger studies are needed to validate these results and refine the protocol further.