Detection of Upper Gastrointestinal Tumour Depth and Demarcation Using Systemic Administration of Indocyanine Green During Endoscopic Submucosal Dissection
Recruiting now · Phase 1/Phase 2
Conditions studied: Esophageal Carcinoma, Gastric Carcinoma
In brief
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.
Key facts
- Study ID
- NCT07108855
- Run by
- University Medical Center Groningen
- People needed
- 10
- Starts
- 2025-09-01
- Expected to finish
- 2027-08-01
- Last updated by the study team
- 2025-08-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
Where it is running
- University Medical Centre Groningen — Groningen, Provincie Groningen, Netherlands (enrolling)
Full record on ClinicalTrials.gov
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