RecruitingPhase 2NCT05745857

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


Sponsor

University Medical Center Groningen

Enrollment

25 participants

Start Date

Sep 15, 2023

Study Type

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

Min Age: 18 Years

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

DRUGAvastin

Orally administered

DRUGErbitux

Orally administered

DEVICEFluorescence endoscopy and multi-diameter single fiber reflectance/single fiber fluorescence (MDSFR/SFF) spectroscopy

Fluorescent endoscope fiber and spectroscopy probe will be inserted through the working channel of the normal clinical therapeutic endoscope


Locations(1)

University Medical Center Groningen

Groningen, Provincie Groningen, Netherlands

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NCT05745857


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