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.
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.
Known allergy to wheat.
Celiac disease.
Dermatitis herpetiformis.
Pregnancy or breastfeeding.
Sequential
WGA-800CW
DrugLectin-based fluorescent tracer
Determine the optimal dose of WGA-800CW (study part A)
Visual evaluation and distinction of tracer during FME (visible signal yes/no)
Determine the optimal dose of WGA-800CW (study part A)
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)
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)
Assess Target-to-background ratio's of patients. When achieving a TBR \> 2 this technique with the WGA-800CW tracer is deemed feasible.
Evaluate the safety of WGA-800CW to detect dysplastic tissue in the esophagus.
To collect safety data on topical administration of WGA-800CW through evaluation of possible SAEs/AEs
Quantify and evaluate the in vivo NIR fluorescent signal of WGA-800CW by using the spectroscopy probe.
Spectroscopy measurements will quantify the WGA-800CW signal in dysplastic lesions. In combination with fluorescence intensities visualized using the FME camera optical prop-erties will be corrected. Thereby providing qualitative and quantitative on fluorescence lesions.
Correlate and validate the fluorescent signals detected in vivo with ex vivo histopathology grade of dysplasia and in the resected muco-sal lesions and/or biopsies taken.
Histopathological score will provide correla-tion and validation between fluorescence and dysplasia. When present, take two additional biopsies of non-fluorescent lesions as nega-tive controls.
To evaluate how OCT-based fluorescence imaging compares with qFME, which is considered the gold standard
In a subset of 15 patients undergoing EMR/ESD, compare fluorescence imaging with qFME to NIRF-OCT. Lesion detected (yes/no)
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