Oral bevacizumab-800CW and cetuximab-800CW to detect early esophageal adenocarcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.