A prospective follow-up Intervention Study: Detection of Early Esophageal Cancer by Near-Infrared Fluorescence molecular Endoscopy using Bevacizumab-800CW

Phase 2

Completed

Conditions: Barrett's Esophagus
10017990
10014713

Registration Number: NL-OMON55871

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 25

Inclusion Criteria

- Suspicion or diagnosed LGD, HGD or superficial EAC and planned diagnostic
and/or therapeutic - endoscopy.
- Age: 18 years or older.
- Written informed consent.

Exclusion Criteria

- Patients younger than 18 years old
- Submucosal and invasive EAC; EAC with TNM-classification other than T1.
- Radiation therapy for esophageal cancer
- Immunoglobulin allergy
- Chemotherapy, immunotherapy or surgery 28 days before administration of the
tracer
- Prior Bevacizumab or Cetuximab treatment
- Patients using anti-epileptic drugs (only exclusion criterium for the ICG
subgroup).
- Non-adjustable hypertension
- 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>- Macroscopic fluorescent signal levels and tracer distribution observed by<br /><br>flexible fluorescence molecular endoscopy.<br /><br>- Macroscopic quantification of the fluorescent signal observed by means of the<br /><br>MDSFR/SFF spectroscopy probe.<br /><br>- Microscopic distribution and (semi-quantitative) fluorescent signal intensity<br /><br>of bevacizumab-IRDye800CW in the EMR specimen and biopsies correlated to VEGF<br /><br>distribution and level of expression.<br /><br>- Ex-vivo we will perform binding experiments with tracers against GREM1,<br /><br>-SULF1 and -PRKCi on the fresh EMR and surgical EC specimen if available and<br /><br>compare them against the in-vivo WLE/NIR-FME findings. We will analyze the<br /><br>sensitivity and specificity of the novel markers alone or in combination. The<br /><br>targeting moieties will be coupled with different fluorophores allowing for<br /><br>multi-parametric analysis.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- The correlation between fluorescence intensity and the grade of VEGF<br /><br>expression on immunohistochemistry, in (pre)malignant lesions of the esophagus.<br /><br>- Adverse events (AE), serious adverse events (SAE), and suspected unexpected<br /><br>serious adverse reactions (SUSARs).<br /><br>- Investigate the binding specificity of Bevacizumab-800CW by comparing<br /><br>the fluorescent intensity results with the results with ICG and Cetuximab-800CW</p><br>