Oral Bevacizumab-800CW and Cetuximab-800CW Administration to Detect Early Esophageal Adenocarcinomas — SLURP  

Esophageal Adenocarcinoma Clinical Trial

Official title: 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

Status Not yet recruiting

Clinical Trial Summary

Previous studies have confirmed the great potential of quantitative fluorescence molecular endoscopy (qFME) when looking at additional lesion detection initially missed by high-definition white light endoscopy (HD-WLE) for surveillance of Barrett's esophagus.

Clinical Trial Description

However, the investigators hypothesized, that additional lesions can potentially be identified by simultaneous use of two targeted tracers because of variable expression of vascular endothelial growth factor A (VEGFA) and epidermal growth factor receptor (EGFR )within oesophageal adenocarcinoma (EAC). Until now, solely intravenous and topical administration of the tracers has been investigated. However, optimization of tracer administration and shortened incubation is necessary for clinical translation and implementation of this new technique from Barrett's esophagus (BE) expert centers to regional non-expert centers. BE surveillance procedures normally takes up to 15 minutes at regional hospitals, of which most of the procedural time is needed to take biopsies according to the Seattle protocol. Introducing qFME into these hospitals would elongate the procedure time with at least 10 - 15 minutes. This would increase healthcare costs and put increased pressure on BE healthcare. Ideally, the gastroenterologist can immediately start with the qFME procedure without any incubation time while maintaining the best target-to-background ratios (TBR) possible. Oral administration by drinking the tracer prior to the procedure would eliminate incubation time and its consequences. Quantified qFME with oral tracer administration and targeted biopsies could potentially replace the time-consuming, high miss rate Seattle protocol, improve lesion detection and decrease global healthcare costs associated with BE. ;

Related Conditions & MeSH terms

• Adenocarcinoma
• Barrett Esophagus
• Barrett Oesophagitis With Dysplasia
• Barrett's Esophagus Without Dysplasia
• Esophageal Adenocarcinoma
• Esophageal Neoplasms
• Esophagitis

• NCT number: NCT05745857
• Study type: Interventional
• Source: University Medical Center Groningen
• Contact: Wouter B Nagengast, Prof. dr.
• Phone: +31(0)503615755
• Email: w.b.nagengast@umcg.nl
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 2023
• Completion date: December 2024