ICG-fluorescence Imaging for Intraoperative Breast Cancer Margins Evaluation: a Dose-timing Study
Recruiting · NCT06227338 · Interventional (participants receive a specific treatment) · Lead sponsor: Jules Bordet Institute
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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 criteria
- 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.
Where it is running
1 location listed.
- Jules Bordet Institute - Brussels, Belgium