VEGF-targeted Fluorescence Near-Infrared (NIR) Endoscopy in (Pre)Malignant Esophageal Lesions (VICE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02129933|
Recruitment Status : Completed
First Posted : May 2, 2014
Last Update Posted : November 25, 2016
|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)|
|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|
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
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)
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)
- 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.
- 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.
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
|University Medical Center Groningen|
|Groningen, Netherlands, 9713 GZ|
|Principal Investigator:||Wouter B Nagengast, PharmD MD PhD||University Medical Center Groningen|
|Principal Investigator:||Frans TM Peters, MD PhD||University Medical Center Groningen|