Actively Recruiting
Detection of Upper Gastrointestinal Tumour Depth and Demarcation by Quantified Fluorescence Molecular Endoscopy 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
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of indocyanine green (ICG)-enhanced near-infrared quantified fluorescence molecular endoscopy (qFME) during endoscopic submucosal dissection (ESD) to better determine the depth and margin of superficial esophageal and gastric adenocarcinomas (T1). These cancers affect the upper gastrointestinal tract, and current techniques may not always fully remove tumors, leading to recurrence risks. This study aims to assess whether ICG-enhanced qFME can improve tumor visualization during ESD. Participants will receive a systemic injection of indocyanine green approximately 30 minutes before undergoing ESD. Near-infrared qFME imaging will then be performed during the endoscopic procedure to help detect tumor boundaries and depth. This method is being studied as a tool to potentially enhance tumor demarcation in the upper gastrointestinal tract. During the study, researchers will evaluate the feasibility of using ICG-enhanced qFME to identify tumor depth and margins one week after the procedure and after study completion within about eight months. They will also assess how well this imaging technique can visualize other nearby structures such as the papilla of Vater and biliary anatomy. Participants will be closely monitored with imaging and assessments related to the endoscopic procedure and fluorescence imaging.
CONDITIONS
Brief 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 endoscopic submucosal dissection
- Age 18 years or older
- Able to provide written informed consent
You will not qualify if you...
- Known allergy to indocyanine green
- Known allergy 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
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of endoscopic submucosal dissection
Participants receive systemic administration of indocyanine green 30 minutes before undergoing endoscopic submucosal dissection with near-infrared quantified fluorescence molecular endoscopy performed during the procedure.
1 treatment visit (in-person)
Duration - 1 week
Participants are monitored to assess the feasibility and visibility outcomes one week after the procedure.
1 follow-up visit (in-person)
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
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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