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临床试验/NCT07108855
NCT07108855招募中1 期

Detection of Upper Gastrointestinal Tumour Depth and Demarcation by Quantified Fluorescence Molecular Endoscopy Using Systemic Administration of Indocyanine Green During Endoscopic Submucosal Dissection

University Medical Center Groningen1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
招募中
入组人数
10
试验地点
1
主要终点
Feasibility of ICG-enhanced qFME to determine tumour demarcation and depth in upper gastrointestinal tumours during ESD

研究概览

简要总结

Endoscopic submucosal dissection (ESD) is a relatively new technique to treat superficial cancers in the upper gastrointestinal (GI) tract. Previous studies reported high en bloc resection rates (95%-97%). However, R0 resection rates (84.5%) suggest that the tumour is not radically removed in all cases, resulting in a risk of tumour recurrence. One of the key challenges is the limited accuracy in determining the depth of cancer invasion. To reduce the risk of tumour recurrence, the endoscopist would greatly benefit from proper and complete visualization of the tumour margin and depth during ESD. Several studies have shown that near-infrared quantified fluorescence molecular endoscopy (qFME) could serve as a red flag detection method and might be a useful imaging tool for tumour demarcation in the upper GI tract. The aim of this study is to evaluate the feasibility of ICG-enhanced near-infrared qFME to determine tumour demarcation and tumour depth in upper GI tumours (e.g. superficial esophageal and/or gastric adenocarcinoma (T1)) during ESD.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

入选标准

  • Patients with confirmed superficial esophageal and/or gastric adenocarcinoma (T1) and are scheduled for ESD within the UMCG;
  • Age of 18 years or older;
  • Able to provide written informed consent.
  • Exclusion Criteria (contraindications for indocyanine green):
  • Known allergy to indocyanine green;
  • Known allergies to iodine, shellfish and/or clams;
  • eGFR < 30 mL/min/1.73 m2;
  • Pregnancy or breastfeeding;
  • Hyperthyroidism.
  • Severe liver disease (ascites and cirrhosis).

排除标准

  • 未提供

研究组 & 干预措施

Systemic administration of ICG

Experimental

Indocyanine Green (ICG) will be administered systemically 30 minutes before endoscopic submucosal dissection (ESD). Near-infrared quantified fluorescence molecular endoscopy (qFME) will be performed during the procedure.

干预措施: Indocyanine Green (IC-Green) (Drug)

Systemic administration of ICG

Experimental

Indocyanine Green (ICG) will be administered systemically 30 minutes before endoscopic submucosal dissection (ESD). Near-infrared quantified fluorescence molecular endoscopy (qFME) will be performed during the procedure.

干预措施: Fluorescence guided identification using indocyanine green (Diagnostic Test)

结局指标

主要结局

Feasibility of ICG-enhanced qFME to determine tumour demarcation and depth in upper gastrointestinal tumours during ESD

时间窗: After study completion, to be expected within 8 months

Fluorescence will also be quantified using mucosal multi-diameter single-fiber reflectance / single-fiber fluorescence (MDSFR/SFF) spectroscopy, a non-invasive measurement technique.

次要结局

  • Visibility of the papilla of Vater and the intraduodenal part of the extrahepatic biliary anatomy by detecting fluorescent signal with ICG-enhanced qFME(One week after the qFME procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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