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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. Identifier: NCT03757507
Recruitment Status : Not yet recruiting
First Posted : November 29, 2018
Last Update Posted : April 12, 2019
Information provided by (Responsible Party):
G.M. van Dam, University Medical Center Groningen

Brief Summary:
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

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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

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arm Intervention/treatment
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 :
  1. 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.

  2. 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 :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Patients above the age of 21 with an indication to undergo a carotid endarterectomy for suspected symptomatic atherosclerotic plaque based on the presence of a CVA and/or transient ischemic attacks (TIA's), including amourosis fugax.

    1. Patients with significant and symptomatic carotid stenosis who are scheduled for carotid endarterectomy as decided by the surgeon or the Multi-Disciplinary Carotid Board

Exclusion Criteria:

  1. Medical or psychiatric condition that compromises the patient's ability to give informed consent
  2. Pregnant or lactating women
  3. Significantrenal(creatinine>110μmol/L)dysfunction
  4. History of iodine allergy or anaphylactic reactions to insect bites or medication or previous allergic reaction to bevacizumab
  5. Presence or history of hyperthyroidism

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Responsible Party: G.M. van Dam, Professor van Dam, University Medical Center Groningen Identifier: NCT03757507     History of Changes
Other Study ID Numbers: 201800515
First Posted: November 29, 2018    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Carotid Stenosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors