EUCTR2013-000100-41-BE进行中（未招募）不适用
Histological study of the (intravenously injected) Indocyanine Green (ICG)distribution in tumour bearing breasts and in axillary pieces of dissection - Histological distribution of ICG in tumor bearing breast and CALND
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •- Patients with histo-pathological diagnosis of mammary cancer who are
- •candidate 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 10
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Diagnosis of mammary cancer established, either by tumorectomy, or
- •by gross biopsy,
- •- Operation foreseen after neo-adjuvant chemotherapy,
- •- Age less than18 years old.
- •- In pre-menopausal women, operation foreseen during the second
- •phase of their cycle,
- •- 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 dissemi-nated 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
研究者
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