ICG-fluorescence imaging for intraoperative breast cancer margins evaluation: a dose-timing study - IJB-IFIBC-2022/01

Institut Jules Bordet0 个研究点目标入组 250 人开始时间: 2023年10月9日最近更新: 2024年7月22日

适应症

试验速览

暂无简介。

•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

•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

发起方

Institut Jules Bordet