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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Medical Center Groningen

About this trial

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.

Eligibility criteria

Qualifiers

Patients with confirmed Barrett's esophagus, esophageal dysplasia, or superficial esophageal ade-nocarcinoma.

Patients scheduled for gastroscopy procedure within the UMCG.

Able to provide written informed consent.

Disqualifiers

Known allergy to wheat.

Celiac disease.

Dermatitis herpetiformis.

Pregnancy or breastfeeding.

Trial design

Treatments tested in this trial

  • WGA-800CW

Treatment groups

49 Participants
are divided into 1 treatment group