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Completed

NCT Number: NCT05588414

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Annecy Genevois, Annecy, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standardization of the sentinel node detection procedure

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.

Primary outcomes

  1. Diagnostic performance (Sensitivity and Specificity) of the indocyanine green fluorescence (ICG) method

    Time frame: 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 :

    • 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.

Secondary outcomes

  1. Frequency and factors associated with the occurrence of false negatives (FN) related to the use of ICG alone (fluorescence tracking failure alone)

    Time frame: 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.

  2. Frequency of detection on table by multispectral camera, of ganglions first detected only by isotopic method.

    Time frame: 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.

  3. 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.

    Time frame: 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.

  4. Surgeon's perception of the usefulness and self-perceived satisfaction of ICG method alone, compared with the combined technique (ICG+TC).

    Time frame: 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).

  5. Interest of the ICG technique alone compared to the combined technique for the detection of metastases.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Annecy Genevois

Other

Registry information

Official study title

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

Acronym: FLUORES

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 20, 2022
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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