Study of the (intravenously injected) ICG distribution in tumour bearing breasts and in axillary pieces of dissection of patients who have received neo-adjuvant therapy for histologically proven mammary cancer

Institut Jules Bordet0 个研究点开始时间: 2013年11月8日最近更新: 2014年10月7日

适应症

试验速览

暂无简介。

•- Patients with histopathological diagnosis of mammary cancer who have received neo-adjuvant therapy and are candidate, either for tumorectomy, or for mastectomy with complete axillary node dissection,
•- 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 20
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Diagnosis of mammary cancer established, either by tumorectomy, or 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

发起方

Institut Jules Bordet