Overview

TRACER [F-18] RDG-K5 Carotid Plaque Imaging Study

Status:
Active, not recruiting

Trial end date:
2020-07-31

Target enrollment:
0

Participant gender:
All

Summary

The purpose of this study is to investigate the ability of a new investigational agent compound [F-18] labeled RGD-K5 to detect unstable atherosclerotic plaque in the carotid artery of subjects being considered for carotid endarterectomy (CEA), and to confirm this ability through tissue analysis of samples of carotid artery plaques that will be collected during the planned carotid surgery. [F-18] RGD-K5 is a radioactive tracer used in imaging to detect active growth of new blood vessels and presence of macrophages. Patients with unstable plaque may be prone to rupture of the plaque due to increase in macrophage activity and growth of new blood vessels. [F-18] RGD-K5 is an investigational agent, which means that it has not yet been approved by the US Food and Drug Administration (FDA). Unstable atherosclerotic plaque that is prone to rupture is characterized by an increase in the number of macrophages and enhanced angiogenesis. Both neovascular endothelium and macrophages exhibit increased Alpha-v beta3 integrin expression. PET (Positron Emission Tomography) imaging of [F-18] RGD-K5 uptake may identify carotid plaque with increased inflammation and neovascularization and may therefore detect unstable plaque in participants with carotid artery stenosis. Prior to Dr. Tamarappoo's relocation to Cedars Sinai Medical Center (CSMC), 5 subjects were enrolled at the Cleveland Clinic where PET-CT (Positron Emission Tomography - Computed Tomography) was performed. 6 subjects will be scanned at Cedars using PET-MRI (Positron emission tomography-magnetic resonance imaging). Based on preliminary data with PET-CTA, the investigator strongly believes the study will be able to reproducibly detect significant [F-18] RGD-K5 uptake in plaque from symptomatic patients. Ultimately, demonstrating preferential [F-18] RGD-K5 uptake in symptomatic patients will significantly impact the way in which patients with carotid plaque (at risk for stroke) are treated and it may prevent unnecessary surgical and endovascular procedures in this population

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Balaji Tamarappoo

Criteria

Inclusion Criteria:

1. Patients presenting

a. to the neurologist for evaluation of stroke or TIA (Symptomatic) with: i. Symptomatic
patients with plaque ≥70% in at least one carotid artery that would be implicated as the
source of embolus responsible for the stroke/TIA. b. or to the vascular surgeon for CEA
(Asymptomatic) with: i. asymptomatic patients with a luminal stenosis of ≥70% in at least
one carotid artery (stable plaque) referred for CEA ii. age-matched by deciles to
symptomatic patients

Exclusion Criteria:

1. stroke due to atrial fibrillation,

2. preexisting carotid stents in the artery of interest,

3. renal dysfunction defined as glomerular filtration rate (GFR) <40ml/min,

4. allergy to gadolinium based contrast agents,

5. Volunteers who have had four or more prior previous gadolinium contrast scans

6. metal implants incompatible with MRI or other condition that prohibits MRI,

7. pregnancy,

8. inability to provide informed consent and

9. age ≤18 years.