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临床试验/EUCTR2020-000509-96-NL
EUCTR2020-000509-96-NL进行中(未招募)1 期

ear-infrared fluorescence imaging using indocyanine green as an adjunct to improve standard-of-care sentinel lymph node procedure in pediatric patients with melanoma or sarcoma of head/neck/trunk, paratesticular or extremities: a feasibility trial - ICG to improve sentinel lymph node procedure in pediatric patients

Princess Maxima Center for pediatric oncology0 个研究点目标入组 22 人开始时间: 2020年4月15日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
22

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
All

入选标准

  • Pediatric patients with melanoma or sarcoma of head/neck/trunk, paratesticular or extremities that have an indication for a sentinel node procedure.
  • Age 0-18 years.
  • Written informed consent from patient/parents/legal guardians, according to local law and regulations.
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range: 22
  • F.1.2 Adults (18-64 years) no
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • 1. Allergy to iodine
  • 2 Hypersensitivity to ICG
  • 3. Kidney insufficiency (eGFR<55)
  • 4. Clinical manifest hyperthyroidism/ autonomous thyroid adenoma
  • 5. Nanocolloid or shell fish allergy (same as in standard care: or Technetium-nanocolloid use)

研究者

发起方
Princess Maxima Center for pediatric oncology

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