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VEGF-targeted Fluorescence Near-Infrared (NIR) Endoscopy in (Pre)Malignant Esophageal Lesions

NCT02129933 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2024-04-16

No results posted yet for this study

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.

Conditions

  • Esophageal Cancer
  • Dysplasia

Interventions

DRUG

Bevacizumab-IRDye800CW

Intravenous administration of a microdose (4.5mg, subtherapeutic) of Bevacizumab-IRDye800CW 2 days prior to the fluorescence endoscopy procedure. \* amendment June 2015: topical administration bevacizumab-800CW (100ug/ml)

DEVICE

Near infrared fluorescence endoscopy platform

A flexible fiber-bundle is attached with its proximal end to a camera which can detect near infrared fluorescent light. The distal end is inserted into the working channel of a clinical video endoscope to visualize the luminal wall. The fluorescent imaging will be performed prior and post the endoscopic resection (within the same endoscopic session)

Sponsors & Collaborators

  • University Medical Center Groningen

    lead OTHER

Principal Investigators

  • Wouter B Nagengast, PharmD MD PhD · University Medical Center Groningen

  • Frans TM Peters, MD PhD · University Medical Center Groningen

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02129933 on ClinicalTrials.gov