EUCTR2014-000298-37-BE
进行中（未招募）
1 期
ear-Infrared fluorescence imaging during neck dissection in head and neck cancer patients after peritumoral injection of Indocyanine Green (a feasibility study)
Jules Borde Institute0 个研究点2014年9月25日
适应症Imaging of lymph nodes to be resected in headand neck cancersTherapeutic area: Diseases [C] - Cancer [C04]
相关药物ICG Pulsion
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Imaging of lymph nodes to be resected in headand neck cancers
- 发起方
- Jules Borde Institute
- 状态
- 进行中（未招募）
- 最后更新
- 9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 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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