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