Study evaluating breast cancer tumorectomy guided by Near-Infrared imaging after the intravenous injection of free Indocyanine Green

Jules Bordet Institute0 个研究点开始时间: 2014年9月10日最近更新: 2016年8月16日

适应症

试验速览

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•- Patients with histopathological diagnosis of mammary cancer who are candidate for tumorectomy, either with SLN selective lymphadenectomy, or with complete axillary node dissection.
•- Patients with tumorectomy foreseen after neo-adjuvant therapy will also be enrolled.
•- Informed consent form signed.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 54
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Diagnosis of mammary cancer established by gross” biopsy.
•- Age less than18 years old.
•- Inability to give informed consent.
•- History of allergy or hypersensitivity against the investigational product (its active substance or ingredients), to iodine or to shellfish.
•- Apparent hyperthyroidism, autonomous thyroid adenoma, unifocal, multifocal or disseminated autonomies of the thyroid gland.
•- Documented coronary disease.
•- Advanced renal impairment (creatinine > 1,5mg/dl).
•- During the 2 weeks before the enrolment, concurrent medication which reduces or increases the extinction of ICG (i.e. anticonvulsants, haloperidol and heparin).
•- Pregnancy, breastfeeding

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