Fluorescein Sodium guided versus other tracer guided sentinel lymph node biopsy in patients with early breast cancer (FLUOSENT): A Randomized controlled trial

Sentinel lymph node biopsy (SLNB) is the standard of care for evaluating axillary node metastasis in early breast cancer patients with a clinically and sonographically negative axilla. Traditional SLNB techniques rely on dual tracers—radioisotopes (e.g., 99mTc radiocolloid) and blue dyes. However, radioisotopes pose challenges, such as a short half-life, logistical complexities, high cost, and safety concerns. Alternatives like Indocyanine Green (ICG) fluorescence dye require expensive equipment, limiting accessibility.

To address these issues, Fluorescein Sodium (FS), which is cost-effective and requires only a blue LED light for fluorescence detection, was developed as a viable alternative. Despite its growing use, there is only one published randomized trial on fluorescein-guided SLNB, underscoring the need for further robust evidence.

The trial aims to evaluate and compare the feasibility and diagnostic performance of Fluorescein Sodium (FS)-guided SLNB against conventional tracers in early breast cancer. It focuses on sentinel lymph node identification rates (SLN-IR), complications, procedure duration, and cost-effectiveness. This multicenter RCT seeks to establish FS as a potentially scalable alternative, especially in resource-limited settings.