Clinical trial NCT05588414: Performance Assessment of the Fluorescence Technique Alone in the Search for the Sentinel Node in Breast Surgery
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Centre Hospitalier Annecy Genevois
Sponsor class: OTHER
First posted: 2022-10-20
Enrollment: 392
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic performance (Sensitivity and Specificity) of the indocyanine green fluorescence (ICG) method
timeFrame: At time of surgery
Secondary outcomes:
measure: Frequency and factors associated with the occurrence of false negatives (FN) related to the use of ICG alone (fluorescence tracking failure alone)
timeFrame: At time of surgery
measure: Frequency of detection on table by multispectral camera, of ganglions first detected only by isotopic method.
timeFrame: At time of surgery
measure: 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.
timeFrame: At time of surgery
measure: Surgeon's perception of the usefulness and self-perceived satisfaction of ICG method alone, compared with the combined technique (ICG+TC).
timeFrame: At time of surgery
measure: Interest of the ICG technique alone compared to the combined technique for the detection of metastases.
timeFrame: Upon receipt of the anatomopathology results
Other outcomes:
Locations:
city: Annecy
country: France
facility: Centre Hospitalier Annecy Genevois
city: Grenoble
country: France
facility: Centre Hospitalier Universitaire Grenoble Alpes
city: Guilherand-granges
country: France
facility: Hôpital Privé Drôme Ardèche
city: Lyon
country: France
facility: Hospices Civils de Lyon - Hôpital de la Croix Rousse
city: Saint-Étienne
country: France
facility: Centre Hospitalier Universitaire de Saint-Etienne
Study officials:
affiliation: Centre Hospitalier Annecy Genevois
name: Didier TARDIF, Doctor
role: PRINCIPAL_INVESTIGATOR
References: