A phase 2 intervention study: Detection of early esophageal neopastic lesions by quantified fluorescence molecular endoscopy using oral and topical administration of bevacizumab-800CW and cetuximab-800CW

Phase 2

Conditions: Barrett's esophagus
10017934
10017991

Registration Number: NL-OMON53297

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 25

Inclusion Criteria

- BE patients without dysplasia and with suspected/diagnosed LGD, 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 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary objectives:<br /><br>The primary objectives are to evaluate the feasibility of oral administration<br /><br>of bevacizumab-800CW and cetuximab-800CW for detection of neoplasia in BE<br /><br>patients compared to HD-WLE to shorten the qFME procedure and test whether<br /><br>combined tracer administration increases lesion detection.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary objectives:<br /><br>1. To collect safety data on oral administration of (combined)<br /><br>bevacizumab-800CW and cetuximab-800CW by spraying.<br /><br>2. To (semi)quantify and evaluate the in vivo NIR fluorescent signal of<br /><br>bevacizumab-800CW and cetuximab-800CW combined by using the spectroscopy probe<br /><br>and compare this to the ex vivo VEGFA/EGFR levels in the resected mucosal<br /><br>lesions and/or biopsies taken.<br /><br>3. Eventually further specify and objectify the improvement of qFME by<br /><br>standardization and tracer administration, by dose optimization, leading to<br /><br>reduction of unnecessary biopsies.</p><br>