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NCT Number: NCT02129933

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

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.

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Key information

Conditions

Esophageal Cancer Digestive System Diseases Digestive System Neoplasms Dysplasia Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bevacizumab-IRDye800CW

Drug

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)

Other names: Beva-800CW, Bevacizumab-800CW, Avastin-800CW (Roche)

Near infrared fluorescence endoscopy platform

Device

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)

Primary outcomes

  1. NIR fluorescent signal in vivo (prior to EMR)

    Time frame: 1 day (endoscopy-day)

    Evaluating presence of specific fluorescent signal in (pre)malignant esophageal lesion in vivo, with use of Near Infrared (NIR) fluorescence endoscopy platform.

Secondary outcomes

  1. Number of participants with adverse events (AE), serious adverse events (SAE) and suspected unexpected serious adverse reactions (SUSAR).

    Time frame: Two days prior and up to 1 week after administration of tracer

    Data collection as a measure of safety and tolerability regarding administration of Bevacizumab-IRDye800CW

  2. VEGF expression ex vivo

    Time frame: up to 1 year

    Correlation between specific fluorescent signal in vivo and ex vivo (observed with near-infrared fluorescence endoscopy) and VEGF expression ex vivo (immunohistochemistry).

  3. NIR fluorescent signal in vivo (wound bed, post EMR)

    Time frame: 1 day (endoscopy-day)

    Presence of specific fluorescence signal in correlation to histological evaluation of specimen (resection margins)

  4. NIR fluorescent signal ex vivo (biopsy and EMR specimen)

    Time frame: up to 1 year

    Evaluation of specific fluorescent signal ex vivo in correlation with observed fluorescence signal during endoscopy procedure.

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

A Pilot Intervention Study for the Use of VEGF-targeted Fluorescence Near-Infrared (NIR) Endoscopy in (Pre)Malignant Esophageal Lesions

Acronym: VICE

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 2, 2014
Registry last updated
Apr 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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