Actively Recruiting
Detection of Upper Gastrointestinal Tumour Depth and Demarcation Using Systemic Administration of Indocyanine Green During Endoscopic Submucosal Dissection
Led by University Medical Center Groningen · Updated on 2025-08-07
10
Participants Needed
1
Research Sites
99 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Detection of Upper Gastrointestinal Tumour Depth and Demarcation Using Systemic Administration of Indocyanine Green During Endoscopic Submucosal Dissection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with confirmed superficial esophageal and/or gastric adenocarcinoma (T1) scheduled for ESD at UMCG
- Age 18 years or older
- Able to provide written informed consent
You will not qualify if you...
- Known allergy to indocyanine green
- Known allergies to iodine, shellfish, or clams
- Estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m2
- Pregnancy or breastfeeding
- Hyperthyroidism
- Severe liver disease such as ascites or cirrhosis
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University Medical Centre Groningen
Groningen, Provincie Groningen, Netherlands, 9713GZ
Actively Recruiting
Research Team
W
Wouter B. Nagengast, MD, PharmD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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