Actively Recruiting
ICG-fluorescence Imaging for Intraoperative Breast Cancer Margins Evaluation: a Dose-timing Study
Led by Jules Bordet Institute · Updated on 2025-02-26
250
Participants Needed
1
Research Sites
98 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
ICG-fluorescence Imaging for Intraoperative Breast Cancer Margins Evaluation: a Dose-timing Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female
- Age 18 years or older
- Histological diagnosis of ductal invasive breast cancer
- Primary early-stage invasive breast cancer (cT1 and/or cT2) without prior breast surgery on the affected breast
- ECOG Performance Status of 0 or 1
- Signed informed consent form before any study procedures
You will not qualify if you...
- Advanced invasive breast cancer (cT3 and/or cT4)
- In situ breast cancer disease
- Lobular invasive breast cancer by histology
- Breast cancer treated with neoadjuvant chemotherapy or endocrine therapy
- Prior history of invasive breast cancer on the affected breast
- Allergy or hypersensitivity to the investigational product or its ingredients
- Allergy to iodine or shellfish
- Hyperthyroidism or thyroid gland autonomy
- Documented coronary disease
- Advanced renal insufficiency (serum creatinine >1.5 mg/dL)
- Chronic liver disease Child-Pugh class B or C
- Use of medications affecting indocyanine green elimination within 2 weeks before surgery
- Pregnant or breastfeeding women
- Unable to give informed consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
Jules Bordet Institute
Brussels, Belgium, 1070
Actively Recruiting
Research Team
F
Florin Pop, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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