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Trial Title:
Performance Assessment of the Fluorescence Technique Alone in the Search for the Sentinel Node in Breast Surgery
NCT ID:
NCT05588414
Condition:
Breast Cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Standardization of the sentinel node detection procedure
Description:
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.
Arm group label:
Indocyanine Green fluorescence method as first step
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre Hospitalier Annecy Genevois
Address:
City:
Annecy
Zip:
74370
Country:
France
Status:
Recruiting
Contact:
Last name:
Didier TARDIF, Doctor
Email:
dtardif@ch-annecygenevois.fr
Facility:
Name:
Centre Hospitalier Universitaire Grenoble Alpes
Address:
City:
Grenoble
Zip:
38043
Country:
France
Status:
Recruiting
Contact:
Last name:
Anne-Cécile PHILIPPE, Doctor
Email:
acphilippe@chu-grenoble.fr
Facility:
Name:
Hôpital Privé Drôme Ardèche
Address:
City:
Guilherand-granges
Zip:
07500
Country:
France
Status:
Recruiting
Contact:
Last name:
Stéphane LANTHEAUME, Doctor
Email:
dr.lantheaume@gmail.com
Facility:
Name:
Hospices Civils de Lyon - Hôpital de la Croix Rousse
Address:
City:
Lyon
Zip:
69004
Country:
France
Status:
Recruiting
Contact:
Last name:
Marion CORTET, Doctor
Email:
marion.cortet@chu-lyon.fr
Facility:
Name:
Centre Hospitalier Universitaire de Saint-Etienne
Address:
City:
Saint-Étienne
Zip:
42055
Country:
France
Status:
Recruiting
Contact:
Last name:
Céline CHAULEUR, Professor
Email:
celine.chauleur@chu-st-etienne.fr
Start date:
December 5, 2022
Completion date:
July 15, 2024
Lead sponsor:
Agency:
Centre Hospitalier Annecy Genevois
Agency class:
Other
Source:
Centre Hospitalier Annecy Genevois
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05588414
