Indocyanine green for axillary sentinel lymph node biopsy in patients with breast cancer (INSEAN study).

Abstract

Introduction: Sentinel lymph node (SLN) detection is the technique of choice for staging early-stage breast cancer (BC). The preferred technique for SLN detection is labelling with the radioisotope Technetium-99 (Tc-99). Other methods have been evaluated, including methylene blue, magnetic tracers, iodine seeds, or fluorescent substances. Various studies have shown the non-inferiority of indocyanine green (ICG) for SLN detection; however, inclusion criteria are selective and restrictive.

Main and secondary hypotheses: Main hypotheses: SLN detection using ICG provides results that are not inferior to those obtained with Tc-99. Secondary hypotheses: METHODS AND DESIGN: This is a multicenter, prospective, observational study in BC patients undergoing primary or post-neoadjuvant surgery with SLN detection. INSEAN study (NCT: 06378944).

Inclusion criteria: Patients of both sexes with cN0 BC undergoing primary surgery or cN1 with good axillary response post-neoadjuvant. The detected nodes will be classified according to the detection method used as "Tc," "Tc + ICG," or "ICG." Final anatomopathological (AP) analysis will be conducted for comparison.

Discussion: The SLN detection rates will be compared across techniques, along with potential adverse effects, definitive AP results, and costs between the two techniques.