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:

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  The combination of ICG and Tc-99 does not increase the average number of SLNs identified in primary surgery but does in the post-neoadjuvant setting.
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  Using ICG does not prolong surgical time once the learning curve is achieved.
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  The cost of ICG is lower than Tc-99.

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.