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2020年4月15日

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: Sentinel node procedure for pediatric patients with melanoma or sarcoma
发起方: Princess Maxima Center for pediatric oncology
入组人数: 22
状态: 进行中（未招募）
最后更新: 2年前

暂无简介。

注册库

who.int

开始日期

2020年4月15日

结束日期

待定

最后更新

2年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

Princess Maxima Center for pediatric oncology

•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

•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)