Oral Bevacizumab-800CW and Cetuximab-800CW Administration to Detect Early Esophageal Adenocarcinomas
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
University Medical Center Groningen
25 participants
Sep 15, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria2
- 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 Criteria8
- 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.
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Interventions
Orally administered
Orally administered
Fluorescent endoscope fiber and spectroscopy probe will be inserted through the working channel of the normal clinical therapeutic endoscope
Locations(1)
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NCT05745857