Clinical trial · Interventional
Performance Assessment of the Fluorescence Technique Alone in the Search for the Sentinel Node in Breast Surgery
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standardization of the sentinel node detection procedure | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Indocyanine Green fluorescence method as first step
- description
- Systematic double identification of the sentinel lymph node, by sequential use of ICG fluorescence technique as first step followed by isotopic technique.
- interventionNames
- Procedure: Standardization of the sentinel node detection procedure
Primary outcomes (1)
- measure
- Diagnostic performance (Sensitivity and Specificity) of the indocyanine green fluorescence (ICG) method
- timeFrame
- At time of surgery
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available