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

NCT05588414 | Completed

• 1 other identifier: 21-04
• Study Type: interventional
• Target: 392
• Locations: 1 country
• Sites: 5

Brief 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

Outcome Measures

Primary Outcomes (1)

• Diagnostic performance (Sensitivity and Specificity) of the indocyanine green fluorescence (ICG) method

  The main objective is to evaluate the diagnostic performance (Sensitivity and Specificity) of the indocyanine green fluorescence (ICG) method alone as a sentinel node marker in non-metastatic breast cancer, compared to the method coupling technetium-99m isotopic research (TC) to fluorescence (Gold Standard in the study centers). The suspicious node bundles, which will have been removed after identification by 1) ICG alone, 2) TC alone or 3) manually, can be classified in a contingency table, according to the first method (the sequence) with which they are detected. The Sensitivity / Specificity pair will then be used to : 1. Estimate the area under the curve (AUC) of the ICG method alone, and its 95% confidence interval. 2. Estimate the positive and negative predictive values of ICG alone, using the prevalence of metastatic lesions.

  At time of surgery

Secondary Outcomes (5)

• Frequency and factors associated with the occurrence of false negatives (FN) related to the use of ICG alone (fluorescence tracking failure alone)

  At time of surgery

• Frequency of detection on table by multispectral camera, of ganglions first detected only by isotopic method.

  At time of surgery

• Causes of premature use of the isotope method (moving to the second stage of tracking) before the first stage of tracking (ICG method) has been completed.

  At time of surgery

• Surgeon's perception of the usefulness and self-perceived satisfaction of ICG method alone, compared with the combined technique (ICG+TC).

  At time of surgery

• Interest of the ICG technique alone compared to the combined technique for the detection of metastases.

  Upon receipt of the anatomopathology results

Study Arms (1)

Indocyanine Green fluorescence method as first step

OTHER

Systematic double identification of the sentinel lymph node, by sequential use of ICG fluorescence technique as first step followed by isotopic technique.

Procedure: Standardization of the sentinel node detection procedure

Interventions

Standardization of the sentinel node detection procedure 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.

Indocyanine Green fluorescence method as first step

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presenting with breast cancer,
• Fulfilling the Sentinel Node search criteria of:
• Patient with carcinoma in situ with high risk of microinvasion:
• nodular presentation, high grade with necrosis,
• suspicion of microinvasion at biopsy,
• radiological size of more than 40 mm,
• need for mastectomy or extensive resection requiring a complex oncoplasty surgery (no size criteria, at the surgeon's discretion)
• Patient with T1-T2 invasive carcinoma AND no lymph node involvement according to Tumor-Node-Metastasis (TNM) classification (N0) on clinical and imaging (negative axillary echo or negative lymph node biopsy):
• unifocal or bifocal proximal tumor
• \< 5 cm (clinical), palpable or non-palpable (subcentimetric allowed)
• in case of neoadjuvant chemotherapy: before or after if N0 and negative axillary echo or negative biopsy
• Benefiting from a French social security system
• Having been informed of the study and having freely given their informed consent to participate in the study.

You may not qualify if:

• Pregnant or breastfeeding patient
• Patient not eligible for the sentinel node procedure (contraindication to surgery, N+ and/or M+ clinical or radiological, T3 and more, history of homolateral breast cancer surgery)
• Patient under guardianship or curators
• Patient under court protection
• Patient who does not understand French
• Patient already included in the study

Sponsors & Collaborators

• Centre Hospitalier Annecy Genevois: lead

Study Sites (5)

Centre Hospitalier Annecy Genevois

Annecy, 74370, France

Location

Centre Hospitalier Universitaire Grenoble Alpes

Grenoble, 38043, France

Location

Hôpital Privé Drôme Ardèche

Guilherand-Granges, 07500, France

Location

Hospices Civils de Lyon - Hôpital de la Croix Rousse

Lyon, 69004, France

Location

Centre Hospitalier Universitaire de Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Didier TARDIF, Doctor

  Centre Hospitalier Annecy Genevois

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: October 20, 2022
• Study Start: December 5, 2022
• Primary Completion: June 27, 2024
• Study Completion: June 27, 2024
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)