Oral bevacizumab-800CW and cetuximab-800CW to detect early esophageal adenocarcinoma
A Phase 2 Intervention Study: Detection of Early Esophageal Neoplastic Lesions by Quantified Fluorescence Molecular Endoscopy Using Oral and Topical Administration of Bevacizumab-800CW and Cetuximab-800CW
This trial tests whether drinking two fluorescent tracers before an endoscopy helps doctors find early esophageal adenocarcinoma in people with Barrett's esophagus or suspected dysplasia.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Medical Center Groningen Academic / other |
| Drugs / interventions | bevacizumab, cetuximab, chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Groningen, Provincie Groningen) |
| Trial ID | NCT05745857 on ClinicalTrials.gov |
What this trial studies
Researchers will give two fluorescently labeled antibodies (bevacizumab-800CW and cetuximab-800CW) orally before endoscopic surveillance in adults with Barrett's esophagus or suspected superficial esophageal adenocarcinoma. During endoscopy they will use quantitative fluorescence molecular endoscopy (qFME) and MDSFR/SFF spectroscopy to visualize tracer uptake and guide targeted biopsies. The approach aims to eliminate incubation time required with intravenous or topical tracers while maintaining high target-to-background ratios. This single-center phase 2 study at University Medical Center Groningen enrolls patients scheduled for diagnostic or therapeutic endoscopy.
Who should consider this trial
Good fit: Adults with Barrett's esophagus (with or without suspected/diagnosed low- or high-grade dysplasia) or superficial (T1) esophageal adenocarcinoma who are scheduled for diagnostic or therapeutic endoscopy and can give informed consent are ideal candidates.
Not a fit: Patients with submucosal or more invasive esophageal cancer beyond T1, prior bevacizumab or cetuximab treatment, recent chemotherapy or radiation, known antibody allergy, pregnancy or breastfeeding, or inability to provide informed consent are unlikely to benefit.
Why it matters
Potential benefit: If successful, oral dual-tracer qFME could help doctors find more early cancers during routine endoscopy, reduce unnecessary biopsies, shorten procedure times, and lower healthcare costs.
How similar studies have performed: Previous studies using qFME with intravenous or topical tracers have shown improved lesion detection compared with white-light endoscopy, but oral dual-tracer administration is a novel approach not yet established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * BE patients without dysplasia and with suspected/diagnosed low-grade dysplasia (LGD), high-grade dysplasia (HGD) or superficial EAC and planned diagnostic and/or therapeutic endoscopy * Written informed consent is obtained Exclusion Criteria: * Patients under the age of eighteen. * Submucosal and invasive EAC, also defined as EAC with tumor, node and metastasis (TNM)-classification other than T1. * Previous radiation therapy for esophageal cancer * Known immunoglobulin allergy * Previous chemotherapy, immunotherapy or related surgery * Prior bevacizumab or cetuximab treatment * Medical or psychiatric conditions that compromise the patient's ability to give informed consent * Pregnancy or breast feeding.
Where this trial is running
Groningen, Provincie Groningen
- University Medical Center Groningen — Groningen, Provincie Groningen, Netherlands (Recruiting)
Study contacts
- Principal investigator: Wouter B. Nagengast, Prof. dr. — University Medical Center Groningen
- Study coordinator: Wouter B Nagengast, Prof. dr.
- Email: w.b.nagengast@umcg.nl
- Phone: +31(0)503615755
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.