EUCTR2013-004498-29-BE
进行中(未招募)
不适用
ear-Infrared fluorescence imaging during neck dissection in head and neck cancer patients after intravenous injection of Indocyanine Green (a feasibility study)
Institut Jules Bordet0 个研究点2013年11月8日
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Imaging of tumoral tissues and of lymph nodes to be resected in head and neck cancers
- 发起方
- Institut Jules Bordet
- 状态
- 进行中(未招募)
- 最后更新
- 11年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •\- All patients requiring neck dissection with or without resection of the primary (the decision and the type of neck dissection are preliminary decided during head and neck multidisciplinary oncologic consultation).
- •\- 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 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
结局指标
主要结局
未指定
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