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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: Standardization of the sentinel node detection procedure

• Study Type: Interventional
• Enrollment (Estimated): 350
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marion GHIDI; Phone Number: +33450637031; Email: drci.promotion@ch-annecygenevois.fr

Study Locations

• France
  • Annecy, France, 74370
    • Recruiting
    • Centre Hospitalier Annecy Genevois
    • Contact: Didier TARDIF, Doctor; Email: dtardif@ch-annecygenevois.fr
  • Grenoble, France, 38043
    • Recruiting
    • Centre Hospitalier Universitaire Grenoble Alpes
    • Contact: Anne-Cécile PHILIPPE, Doctor; Email: acphilippe@chu-grenoble.fr
  • Guilherand-granges, France, 07500
    • Recruiting
    • Hôpital privé Drôme Ardèche
    • Contact: Stéphane LANTHEAUME, Doctor; Email: dr.lantheaume@gmail.com
  • Lyon, France, 69004
    • Recruiting
    • Hospices Civils de Lyon - Hopital de la Croix Rousse
    • Contact: Marion CORTET, Doctor; Email: marion.cortet@chu-lyon.fr
  • Saint-Étienne, France, 42055
    • Recruiting
    • Centre Hospitalier Universitaire de Saint-Étienne
    • Contact: Céline CHAULEUR, Professor; Email: celine.chauleur@chu-st-etienne.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 : Estimate the area under the curve (AUC) of the ICG method alone, and its 95% confidence interval.; Estimate the positive and negative predictive values of ICG alone, using the prevalence of metastatic lesions.	At time of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency and factors associated with the occurrence of false negatives (FN) related to the use of ICG alone (fluorescence tracking failure alone)	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.	At time of surgery
Frequency of detection on table by multispectral camera, of ganglions first detected only by isotopic method.	Number and percentage of ganglion bundles detected only by isotopic method, among which we will finally find a marking with the multispectral camera.	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.	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.	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).	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).	At time of surgery
Interest of the ICG technique alone compared to the combined technique for the detection of metastases.	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.	Upon receipt of the anatomopathology results

Collaborators and Investigators

• Sponsor: Centre Hospitalier Annecy Genevois
• Investigators: Principal Investigator: Didier TARDIF, Doctor, Centre Hospitalier Annecy Genevois

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2022
• Primary Completion (Estimated): July 15, 2024
• Study Completion (Estimated): July 15, 2024

Study Registration Dates

• First Submitted: October 14, 2022
• First Submitted That Met QC Criteria: October 18, 2022
• First Posted (Actual): October 20, 2022

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: August 7, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 21-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No