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VEGF-targeted Fluorescence Near-Infrared (NIR) Endoscopy in (Pre)Malignant Esophageal Lesions (VICE)
This study has been completed.
Sponsor:
University Medical Center Groningen
Information provided by (Responsible Party):
dr. W.B. Nagengast, MD, University Medical Center Groningen
ClinicalTrials.gov Identifier:
NCT02129933
First received: April 24, 2014
Last updated: November 23, 2016
Last verified: November 2016
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Esophageal Cancer Dysplasia | Drug: Bevacizumab-IRDye800CW Device: Near infrared fluorescence endoscopy platform | Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | A Pilot Intervention Study for the Use of VEGF-targeted Fluorescence Near-Infrared (NIR) Endoscopy in (Pre)Malignant Esophageal Lesions |
Resource links provided by NLM:
MedlinePlus related topics:
Endoscopy
Drug Information available for:
Bevacizumab
U.S. FDA Resources
Further study details as provided by dr. W.B. Nagengast, MD, University Medical Center Groningen:
Primary Outcome Measures:
- 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 Outcome Measures:
- 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
- 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).
- 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)
- 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.
| Enrollment: | 14 |
| Study Start Date: | April 2014 |
| Study Completion Date: | November 2016 |
| Primary Completion Date: | November 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Tracer bevacizumab-IRDye800CW
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 |
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) Other Names:
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)
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02129933
Please refer to this study by its ClinicalTrials.gov identifier: NCT02129933
Locations
| Netherlands | |
| University Medical Center Groningen | |
| Groningen, Netherlands, 9713 GZ | |
Sponsors and Collaborators
University Medical Center Groningen
Investigators
| Principal Investigator: | Wouter B Nagengast, PharmD MD PhD | University Medical Center Groningen |
| Principal Investigator: | Frans TM Peters, MD PhD | University Medical Center Groningen |
More Information
| Responsible Party: | dr. W.B. Nagengast, MD, PharmD MD PhD, University Medical Center Groningen |
| ClinicalTrials.gov Identifier: | NCT02129933 History of Changes |
| Other Study ID Numbers: |
NL45554.042.14 2013-003003-19 ( EudraCT Number ) |
| Study First Received: | April 24, 2014 |
| Last Updated: | November 23, 2016 |
Keywords provided by dr. W.B. Nagengast, MD, University Medical Center Groningen:
|
EAC HGD Esophagus |
Additional relevant MeSH terms:
|
Esophageal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms Digestive System Diseases Esophageal Diseases |
Gastrointestinal Diseases Bevacizumab Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents |
ClinicalTrials.gov processed this record on July 17, 2017