RecruitingNot ApplicableNCT06227338

ICG-fluorescence Imaging for Intraoperative Breast Cancer Margins Evaluation: a Dose-timing Study

Sponsor

Jules Bordet Institute

Enrollment

250 participants

Start Date

Feb 12, 2024

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

Summary

Designed in five-arm, single-center, prospective randomized, observational- interventional, open-label study which will evaluate patients with histological proven early-stage BC that will undergo planned BCS for their local treatment. Two preoperatively times frames will be used for the administration of a total of 5 different indocyanine green (ICG) dose as a single dose-patient arm. In the first time frame (intraoperative arms), the dose of, respectively 0.125 mg/kg and 0.25 mg/kg of ICG will be administered at induction anesthesia (at least 20 minutes before the BCS) in two subgroups. In the second time frame, (preoperative arms), the dose of, respectively, 0.5 mg/kg, 1 mg/kg, and 2 mg/kg of ICG will be administered 24 h before surgery in 3 subgroups.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria6

female;
age of ≥18 years;
histological diagnosis of ductal invasive breast cancer;
a primary early-stage invasive breast cancer (cT1 and/or cT2, assessed clinically and/or radiologically), without prior BC surgery of the actually affected breast;
ECOG Performance Status (PS) 0 or 1;
signed informed consent form (ICF) obtained prior to any study related procedure.

Exclusion Criteria14

advanced invasive breast cancer (cT3 and/or cT4);
in situ breast cancer disease;
lobular invasive breast cancer (at histology);
invasive breast cancer treated by neoadjuvant chemotherapy and/or endocrine therapy;
prior history of invasive or breast cancer of the actually affected breast in the past;
history of allergy or hypersensitivity to investigational product (active substance or ingredients);
history of allergy to iodine or to shellfish;
have apparent hyperthyroidism, autonomous thyroid adenoma, unifocal, multifocal, or disseminated autonomy of the thyroid gland;
documented coronary disease
advanced renal insufficiency (serum creatinine \>1.5 mg/dL);
chronic liver disease with the Child-Pugh class B or C ;
concurrent medication which reduces or increases the elimination of indocyanine green dye (ie, anticonvulsants, haloperidol, and heparin) during the 2 weeks before the expected operation;
pregnant or lactating women;
inability to give informed consent.

Interventions

DRUGIndocyanine green

Indocyanine green dye (Diagnostic Green) will be diluted with sterile water and a specific dose-arm (0.125 mg/kg, 0.25 mg/kg, 05 mg/kg, 1 mg/kg, and 2 mg/kg) will be administrated by slow intravenous injection by peripheral venous catheter: * at induction anaesthesia of the surgical procedure (0.125 mg/kg or 0.25mg/kg), or * in the hospital room 24 hours before the breast surgery (05 mg/kg, or 1 mg/kg, or 2 mg/kg).