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

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ClinicalTrials.gov Identifier: NCT02129933
Recruitment Status : Completed
First Posted : May 2, 2014
Last Update Posted : November 25, 2016
Sponsor:
Information provided by (Responsible Party):
dr. W.B. Nagengast, MD, University Medical Center Groningen

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.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Dysplasia Drug: Bevacizumab-IRDye800CW Device: Near infrared fluorescence endoscopy platform Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2014
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
Drug Information available for: Bevacizumab
U.S. FDA Resources

Arm Intervention/treatment
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:
  • 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)



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 )
First Posted: May 2, 2014    Key Record Dates
Last Update Posted: November 25, 2016
Last Verified: November 2016

Keywords provided by dr. W.B. Nagengast, MD, University Medical Center Groningen:
EAC
HGD
Esophagus

Additional relevant MeSH terms:
Esophageal Neoplasms
Esophageal Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents