ICG-fluorescence imaging for intraoperative breast cancer margins evaluation: a dose-timing study

Phase 1

Recruiting

Conditions: Patients with primary invasive early breast cancer (T1-T2) that will undergo planned breast-conserving surgery
MedDRA version: 20.0Level: PTClassification code: 10075713Term: Invasive breast carcinoma Class: 100000004864
MedDRA version: 20.0Level: PTClassification code: 10076783Term: Breast conserving surgery Class: 100000004865
Therapeutic area: Diseases [C] - Neoplasms [C04]

Registration Number: CTIS2023-504024-26-00

Lead Sponsor: Institut Jules Bordet

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 250

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, 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, 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