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

NCT ID: NCT05588414

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 392 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-05
• Study Completion Date: 2024-06-27

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Indocyanine Green fluorescence method as first step

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

Group Type: OTHER

Standardization of the sentinel node detection procedure

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patient over 18 years of age on the day of inclusion,
• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Annecy Genevois

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Didier TARDIF, Doctor

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Annecy Genevois

Locations

Centre Hospitalier Annecy Genevois

Annecy, , France

Centre Hospitalier Universitaire Grenoble Alpes

Grenoble, , France

Hôpital Privé Drôme Ardèche

Guilherand-Granges, , France

Hospices Civils de Lyon - Hôpital de la Croix Rousse

Lyon, , France

Centre Hospitalier Universitaire de Saint-Etienne

Saint-Etienne, , France

Countries

France

Other Identifiers

21-04

Identifier Type: -

Identifier Source: org_study_id