Investigation of Plaque Instability Using Bevacizumab-800CW and MSOT (Carotid)
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03757507|
Recruitment Status : Not yet recruiting
First Posted : November 29, 2018
Last Update Posted : April 12, 2019
G.M. van Dam
Information provided by (Responsible Party):
G.M. van Dam, University Medical Center Groningen
Determining whether we could visualize uptake of the fluorescent tracer Bevacizumab-800CW, targeting VEGF-A in atherosclerotic plaques by using the new imaging technique Multispectral Optoacoustic Tomography both in- and ex vivo.
|Condition or disease||Intervention/treatment||Phase|
|Atherosclerosis Carotid Stenosis Fluorescence||Device: MultiSpectral Optoacoustic Tomography||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open label, single group|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Investigation of Plaque Instability: Identification of Atherosclerotic Plaque Angiogenesis Using Bevacizumab-800CW and Optoacoustic Imaging: a Single Center Proof of Concept Study (CAROTID-OPTOLIGHT)|
|Estimated Study Start Date :||April 10, 2019|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||March 1, 2020|
Experimental: Optoacoustic imaging
Optoacoustic Imaging before and after tracer administration
Device: MultiSpectral Optoacoustic Tomography
Multispectral Optoacoustic Tomography is a new emerging imaging technique which uses laser light to heat up molecules with a high pulsed laser. The molecules undergo thermal expansion and produces sound waves, which can be detected by special transducers. The device can pick up different signals in different wavelength to produce images with anatomic and biological information.
Primary Outcome Measures :
- Feasibility of MSOT imaging [ Time Frame: 12 months ]Feasibility of optoacoustic imaging to image the carotid artery and detect plaque formation in patients with symptomatic carotid artery disease.
- Ex vivo imaging [ Time Frame: 12 months ]Pre-operative detection of the atherosclerotic plaque in symptomatic carotid stenosis by the VEGF-targeted optical imaging agent optical imaging agent Bevacizumab-800CW using optoacoustic imaging subsequently correlated ex vivo for VEGF upregulation within the plaque indicative for increased angiogenesis.
Secondary Outcome Measures :
- Location of Fluorescence [ Time Frame: 12 months ]Presence of fluorescent signaling after excision of the atherosclerotic plaque ex vivo as determined by flatbed scanning and fluorescence microscopy.
No Contacts or Locations Provided