跳至主要内容
临床试验/EUCTR2013-004498-29-BE
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。

注册库
who.int
开始日期
2013年11月8日
结束日期
待定
最后更新
11年前
研究类型
Interventional clinical trial of medicinal product
性别
All

研究者

发起方
Institut Jules Bordet

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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