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
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Unknown
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