EUCTR2013-000276-15-BE进行中(未招募)1 期
Feasibility study of the (intravenously injected) Indocyanine green (ICG) imaging of tumoral implants in patients with peritoneal carcinomatosis from ovarian carcinoma
相关药物
试验速览
- 阶段
- 1 期
- 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 (either newly diagnosed, or relapsing) with histo-pathological diagnosis of ovarian carcinoma and peritoneal carcinomatosis who are candidate for open” surgery, either after neo-adjuvant chemotherapy (80-90% of the cases), or in first intent”.
- •- 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
- •- 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 dissemi-nated autonomies of the thyroid gland.
- •- Documented coronary disease.
- •- Advanced renal impairment (creatinine > 1,5mg/dl).
研究者
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