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

Centre Hospitalier Annecy Genevois

Status: Completed

Conditions: Breast Cancer

Treatments: Procedure: Standardization of the sentinel node detection procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT05588414

21-04

Details and patient eligibility

About

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.

Enrollment: 392 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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392 participants in 1 patient group

Indocyanine Green fluorescence method as first step

Other group

Description:

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

Treatment:

Procedure: Standardization of the sentinel node detection procedure