Investigation of Plaque Instability Using Bevacizumab-800CW and MSOT

NCT03757507 | Unknown DMC

• 1 other identifier: 201800515
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atherosclerosis; Carotid Stenosis; Fluorescence

Outcome Measures

Primary Outcomes (2)

• Feasibility of MSOT imaging

  Feasibility of optoacoustic imaging to image the carotid artery and detect plaque formation in patients with symptomatic carotid artery disease.

  12 months

• Ex vivo imaging

  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.

  12 months

Secondary Outcomes (1)

• Location of Fluorescence

  12 months

Study Arms (1)

Optoacoustic imaging

EXPERIMENTAL

Optoacoustic Imaging before and after tracer administration

Device: MultiSpectral Optoacoustic Tomography

Interventions

MultiSpectral Optoacoustic Tomography DEVICE

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.

Optoacoustic imaging

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• G.M. van Dam: lead

MeSH Terms

Conditions

Atherosclerosis; Carotid Stenosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor van Dam

Model Details: Open label, single group

Study Record Dates

• First Submitted: November 26, 2018
• First Posted: November 29, 2018
• Study Start: April 10, 2019
• Primary Completion: December 31, 2019
• Study Completion: March 1, 2020
• Last Updated: April 12, 2019

Record last verified: 2019-04