NCT05588414

Performance Assessment of the Fluorescence Technique Alone in the Search for the Sentinel Node in Breast Surgery

Performance Assessment of the Fluorescence Technique Alone in the Search for the Sentinel Node in Breast Surgery, Compared to the Use of the Combined Fluorescence and Isotopic Method

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 392 (actual)
• Sponsor: Centre Hospitalier Annecy Genevois · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Cohort, interventional, multicenter, non-randomized study to compare the performance of the ICG fluorescence technique (ICG) alone to the combined ICG + isotopic technique in the detection of sentinel node. Comparison of the performances of two techniques used in current practice, without modification of the patients' care plan. Indeed, all patients receive both techniques, but the protocol allows to standardize the collection of the performances of each of the two techniques in order to compare them.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	Standardization of the sentinel node detection procedure	All patients included in the study underwent the same pre- and intra-operative procedure, consisting of a double systematic sentinel node detection, using sequential ICG and isotopic technique. The patient is his own control for the analysis of the performance of the ICG technique alone compared to the combined ICG and isotopic technique.

Timeline

• Start date: 2022-12-05
• Primary completion: 2024-06-27
• Completion: 2024-06-27
• First posted: 2022-10-20
• Last updated: 2025-02-13

Locations

5 sites across 1 country: France