VEGF-targeted Fluorescence Near-Infrared (NIR) Endoscopy in (Pre)Malignant Esophageal Lesions
Conditions
Esophageal Cancer - Dysplasia
Conditions: official terms
Esophageal Neoplasms
Conditions: Keywords
EAC, HGD, Esophagus
Study Type
Interventional
Study Phase
Phase 1
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: Bevacizumab-IRDye800CW Type: Drug
Name: Near infrared fluorescence endoscopy platform Type: Device
Overall Status
Recruiting
Summary
To improve detection of esophageal (pre)malignant lesions during surveillance endoscopy of patients at risk of developing malignancies, for example in Barrett's Esophagus (BE), there is a need for better endoscopic visualization and the ability for targeted biopsies. Optical molecular imaging of neoplasia associated biomarkers could form a promising technique to accommodate this need. It is known that the biomarker Vascular Endothelial Growth Factor (VEGF) is overexpressed in dysplastic and neoplastic areas in BE segments versus normal tissue and has proven to be a valid target for molecular imaging. The University Medical Center Groningen (UMCG) developed a fluorescent tracer by labeling the VEGF-targeting humanized monoclonal antibody bevacizumab, currently used in anti-cancer therapy, with the fluorescent dye IRDye800CW. We hypothesize that when bevacizumab-IRDye800CW is administered, it accumulates in VEGF expressing high grade dysplasia (HGD) and esophageal adenocarcinoma (EAC), enabling early cancer visualization using a newly developed fluorescent NIR fiber-bundle. This hypothesis will be tested in this pilot intervention study.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Identified HGD or intramucosal EAC (T1) and therefore candidate for endoscopic mucosal resection therapy

- Mentally competent person, 18 years or older.

- Written informed consent.

- Adequate potential for follow-up.

Exclusion Criteria:

- Medical or psychiatric conditions that compromise the patient's ability to give informed consent.

- Submucosal and invasive EAC; EAC with tumor-classification other than T1.

- Concurrent (uncontrolled) medical conditions which disqualify for an endoscopic mucosal resection procedure.

- Previously performed therapeutic endoscopic procedures.

- Pregnancy or breast feeding.
Location
University Medical Center Groningen
Groningen, Netherlands
Status: Recruiting
Contact: Wouter B Nagengast, PharmD MD PhD - 0031503615755 - w.b.nagengast@umcg.nl
Start Date
April 2014
Completion Date
May 2015
Sponsors
University Medical Centre Groningen
Source
University Medical Centre Groningen
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page