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

This study has been completed.

Sponsor:

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

History of Changes

Tracking Information

First Received Date ^ICMJE

April 24, 2014

Last Updated Date

November 23, 2016

Start Date ^ICMJE

April 2014

Primary Completion Date

November 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT02129933 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Condition ^ICMJE

Esophageal Cancer
Dysplasia

Intervention ^ICMJE

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:
- Beva-800CW
- Bevacizumab-800CW
- Avastin-800CW (Roche)
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)

Study Arms

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

Interventions:

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2016

Primary Completion Date

November 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Netherlands

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT02129933

Other Study ID Numbers ^ICMJE

NL45554.042.14
2013-003003-19 ( EudraCT Number )

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

dr. W.B. Nagengast, MD, University Medical Center Groningen

Study Sponsor ^ICMJE

University Medical Center Groningen

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Wouter B Nagengast, PharmD MD PhD	University Medical Center Groningen
Principal Investigator:	Frans TM Peters, MD PhD	University Medical Center Groningen

PRS Account

University Medical Center Groningen

Verification Date

November 2016

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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