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

University Medical Center Groningen (UMCG)

Status and phase: Completed; Phase 1

Conditions: Dysplasia; Esophageal Cancer

Treatments: Drug: Bevacizumab-IRDye800CW; Device: Near infrared fluorescence endoscopy platform

Study type: Interventional

Funder types: Other

Identifiers

NCT02129933

2013-003003-19 (EudraCT Number)

NL45554.042.14

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Tracer bevacizumab-IRDye800CW

Experimental group

Description:

Two days prior to the fluorescence endoscopy procedure (with the near infrared fluorescence endoscopy platform), all patients will receive the fluorescent tracer bevacizumab-IRDye800CW intravenously. \*amendement June 2015: topical administration of bevacizumab-800CW

Treatment:

Drug: Bevacizumab-IRDye800CW

Device: Near infrared fluorescence endoscopy platform