NCT07643727

Brief 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 Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P50-P75 for phase_1

Timeline
29mo left

Started Jun 2026

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Jun 2026Oct 2028

First Submitted

Initial submission to the registry

June 1, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 11, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2028

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2028

Last Updated

June 11, 2026

Status Verified

February 1, 2026

Enrollment Period

1.8 years

First QC Date

June 1, 2026

Last Update Submit

June 8, 2026

Conditions

Barrett's Esophagus With or Without DysplasiaBarrett Esophagus Adenocarcinoma

Keywords

GlycanOncologyFluorescent tracersqFMEFirst-in-humanLectin

Outcome Measures

Primary Outcomes (5)

  • Determine the optimal dose of WGA-800CW (study part A)

    Visual evaluation and distinction of tracer during FME (visible signal yes/no)

    From enrollment to inclusion and data assessment of patient 9.

  • 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).

    From enrollment to inclusion and data assessment of patient 9.

  • Determine the optimal dose of WGA-800CW (study part A)

    Calculate mean fluorescence intensities of biopsies by scanning with odyssey fluorescence scanner

    From enrollment to inclusion and data assessment of patient 9

  • 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.

    From enrollment till the last patient included.

  • Determine the optimal dose of WGA-800CW (study part A)

    By assessing quantitative spectroscopy measurements indicating fluorescence signal intensity in lesion area and non-dysplastic BE.

    From enrollment to inclusion and data assessment of patient 9

Secondary Outcomes (7)

  • Evaluate the safety of WGA-800CW to detect dysplastic tissue in the esophagus.

    During patient enrollment

  • Quantify and evaluate the in vivo NIR fluorescent signal of WGA-800CW by using the spectroscopy probe.

    During enrollment

  • 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.

    During enrollment

  • To evaluate how OCT-based fluorescence imaging compares with qFME, which is considered the gold standard

    During enrollment

  • Evaluate the safety of WGA-800CW to detect dysplastic tissue in the esophagus.

    During patient enrollment

  • +2 more secondary outcomes

Study Arms (1)

WGA-800CW

EXPERIMENTAL
Drug: WGA-800CW

Interventions

WGA-800CWDRUG

Lectin-based fluorescent tracer

WGA-800CW

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Known allergy to wheat.
  • Celiac disease.
  • Dermatitis herpetiformis.
  • Pregnancy or breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, Provincie Groningen, 9713 GZ, Netherlands

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • W.B. Nagengast, Dr, MD

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan Shaheen, PharmD

CONTACT

+31621927538j.shaheen@umcg.nl

Chair/Head of the Department of Gastroenterology and Hepatolog

CONTACT

+31503616161w.b.nagengast@umcg.nl

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2026

First Posted

June 11, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

October 31, 2028

Last Updated

June 11, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations

NL(1)