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

NCT05588414 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 392

Last updated 2025-02-13

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Centre Hospitalier Annecy Genevois

    lead OTHER

Principal Investigators

  • Didier TARDIF, Doctor · Centre Hospitalier Annecy Genevois

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-05
Primary Completion
2024-06-27
Completion
2024-06-27

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05588414 on ClinicalTrials.gov