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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Procedure: Standardization of the sentinel node detection procedure

• Registration Number: NCT05588414
• Lead Sponsor: Centre Hospitalier Annecy Genevois

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-14
• Study First Submitted QC: 2022-10-18
• Study First Posted: 2022-10-20
• Study Start: 2022-12-05
• Primary Completion: 2024-06-27
• Study Completion: 2024-06-27
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 392

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Indocyanine Green fluorescence method as first step	Standardization of the sentinel node detection procedure	Systematic double identification of the sentinel lymph node, by sequential use of ICG fluorescence technique as first step followed by isotopic technique.

Primary Outcome Measures

Name	Time	Method
Diagnostic performance (Sensitivity and Specificity) of the indocyanine green fluorescence (ICG) method	At time of surgery	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.

Secondary Outcome Measures

Name	Time	Method
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	The number and percentage of lymph node packages detected only by isotopic method. Analysis of the factors (patient characteristics such as total mastectomy vs. partial mastectomy, obesity, tumor location in the mammary gland) associated with the occurrence of these false negatives, using a multivariate logistic regression model.
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	Frequencies of pre-identified causes of premature isotopic use during the first stage of the axillary procedure. The pre-identified causes are the follows: * Poor skin visualization; * Operative difficulty with persistence of a fluorescent signal; * Loss of fluorescent signal; * Loss of surgeon patience; * Other.
Interest of the ICG technique alone compared to the combined technique for the detection of metastases.	Upon receipt of the anatomopathology results	Diagnostic performance of ICG method to identify sentinel node will be associated with the frequency of detection of metastases (weighted by the number of nodes present in the lymph node packages sent to pathology) in order to evaluate the diagnostic performance of this method as sentinel metastatic node marker.
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	Description of the surgeon's self-perceived satisfaction with the use of the ICG alone, using individualized 10-point Likert scales (0 = not at all useful/satisfied; 10 = quite useful/satisfied).
Frequency of detection on table by multispectral camera, of ganglions first detected only by isotopic method.	At time of surgery	Number and percentage of ganglion bundles detected only by isotopic method, among which we will finally find a marking with the multispectral camera.

Trial Locations

Locations (5)

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-Étienne, France