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

Condition(s) studied

Investigational drug(s) / intervention(s)

WGA-800CW: Lectin-based fluorescent tracer

Study 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.

Eligibility

Primary outcome measure(s)

• Determine the optimal dose of WGA-800CW (study part A) — From enrollment to inclusion and data assessment of patient 9.
  Visual evaluation and distinction of tracer during FME (visible signal yes/no)
• Determine the optimal dose of WGA-800CW (study part A) — From enrollment to inclusion and data assessment of patient 9.
  Calculating Target-to-background ratio's by dividing fluorescence intensity of target (dysplastic lesion) by the fluorescence intensity of the background (non-dysplastic BE).
• Determine the optimal dose of WGA-800CW (study part A) — From enrollment to inclusion and data assessment of patient 9
  Calculate mean fluorescence intensities of biopsies by scanning with odyssey fluorescence scanner
• Determine the feasibility for detection of dysplastic esophageal lesions with WGA-800CW intra-procedurally (study part B) — From enrollment till the last patient included.
  Assess Target-to-background ratio's of patients. When achieving a TBR \> 2 this technique with the WGA-800CW tracer is deemed feasible.
• Determine the optimal dose of WGA-800CW (study part A) — From enrollment to inclusion and data assessment of patient 9
  By assessing quantitative spectroscopy measurements indicating fluorescence signal intensity in lesion area and non-dysplastic BE.

Trial sites (1)

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