RecruitingPhase 1Phase 2NCT07108855

Detection of Upper Gastrointestinal Tumour Depth and Demarcation Using Systemic Administration of Indocyanine Green During Endoscopic Submucosal Dissection

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


Sponsor

University Medical Center Groningen

Enrollment

10 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether injecting a dye called indocyanine green (ICG) into the bloodstream can help doctors better see the edges and depth of early-stage esophageal or stomach tumors during a minimally invasive procedure called endoscopic submucosal dissection (ESD). This could help surgeons remove tumors more precisely. **You may be eligible if:** - You have been diagnosed with a superficial (early-stage, T1) esophageal or stomach cancer - You are scheduled for ESD at the participating hospital - You are 18 or older and can provide written consent **You may NOT be eligible if:** - You have a known allergy to indocyanine green - You have allergies to iodine, shellfish, or clams - Your kidney function is significantly reduced (eGFR below 30) - You are pregnant or breastfeeding - You have an overactive thyroid (hyperthyroidism) - You have severe liver disease (cirrhosis with ascites) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIndocyanine Green (IC-Green)

Systemic administration of indocyanine green during the endoscopic procedure.

DIAGNOSTIC_TESTFluorescence guided identification using indocyanine green

Near-infrared quantified fluorescence molecular endoscopy (qFME) will be used during the endoscopic procedure.


Locations(1)

University Medical Centre Groningen

Groningen, Provincie Groningen, Netherlands

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NCT07108855


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