Clinical Trial

Development of Fluorescent Lectin Tracers With Dedicated Technology for in Vivo Detection of Esophageal Dysplasia in Barrett Patients

Study acronym: GRAIN
Not Yet Recruiting Phase 1
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Summary
The goal of this clinical trial is to evaluate the feasibility of WGA-800CW with dedicated imaging systems for detection of invisible esophageal dysplasia in patients with Barrett's esophagus. The main questions it aims to answer are: * What is the optimal dose of WGA-800CW that maximizes the tumor-to-background ratio and enables clear visualization of the tumor? * Can fluorescence endoscopy with WGA-800CW in combination with qFME detect dysplastic esophageal lesions? In this non-randomized, non-blinded, prospective, feasibility intervention study, 49 participants with Barrett's esophagus will be included. Patients will undergo the combined procedure (qFME and/or OCT-NIRF and HD-WLE). WGA-800CW will be topically administered via a spray catheter during gastroscopy procedures and fluorescent signal will be assessed with qFME and/or OCT-NIRF.
Trial Details
NCT Number NCT07643727
Lead Sponsor University Medical Center Groningen
Conditions Barrett's Esophagus With or Without Dysplasia, Barrett Esophagus Adenocarcinoma
Enrollment 49 participants
Start Date 2026-06-01
Primary Completion 2028-03-31 (estimated)
Study Completion 2028-10-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-11