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RECRUITING
NCT07108855
PHASE1/PHASE2

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

Sponsor: University Medical Center Groningen

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2025-09-01

Completion Date

2027-08-01

Last Updated

2025-08-07

Healthy Volunteers

No

Interventions

DRUG

Indocyanine Green (IC-Green)

Systemic administration of indocyanine green during the endoscopic procedure.

DIAGNOSTIC_TEST

Fluorescence 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