RecruitingPhase 2

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

Netherlands25 participantsStarted 2023-09-15

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

Feasibility of shortening qFME procedural time by oral administration of bevacizumab-800CW and cetuximab-800CW for the detection of BE neoplasia.

Timeframe: 12 months

Evaluate if the combination of tracers improves lesion detection by the number of invisible lesions detected

Timeframe: 12 months

Trial details

NCT IDNCT05745857

SponsorUniversity Medical Center Groningen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05

Contact for this trial

Wouter B Nagengast, Prof. dr.

+31(0)503615755 w.b.nagengast@umcg.nl

View on ClinicalTrials.gov More Barrett's Esophagus Without Dysplasia trials