NCT04761172Unknown2 期
Near-infrared Fluorescence Imaging With IndoCyanine Green for the Intraoperative Identification of Gastrointestinal Stromal Cell Tumours: a Pilot Study
Leiden University Medical Center2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2020年6月17日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Primary tumor detection
研究概览
简要总结
This is an open-label pilot study including 10 GIST patients scheduled for an elective open or laparoscopic resection at Leiden University Medical Center (LUMC) and Erasmus Medical Center (EMC), Rotterdam. Patients will receive a single dose injection of 10mg ICG at a given moment during the 24 hours prior to surgery or during surgery. The timing of administration will be determined according to a step-up, step-down procedure. Standard of care surgery will be performed and a NIR fluorescence imaging system will be used to record the GIST under fluorescence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with GIST by histology or cytology, localized or metastasized, scheduled to undergo an elective open or laparoscopic resection.
排除标准
- •History of an allergy or hypersensitivity to sodium iodide, iodine or ICG
- •Patients with hyperthyroidism and patients with an autonomous thyroid adenoma
- •Patients pregnant or breastfeeding
- •Patients with severe renal insufficiency (eGFR <30)
结局指标
主要结局
Primary tumor detection
时间窗: Intra-operative
Tumor detection perceived by the surgeon with and without NIR-imaging
次要结局
- Tumor to background ratio(Through study completion, estimated to be 6 months)
- Detection of peritoneal tumor depositions(Intra-operative)
研究者
javanderhage
Prof. dr.
Leiden University Medical Center
研究点 (2)
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