Status:
COMPLETED
TRACER [F-18] RDG-K5 Carotid Plaque Imaging Study
Lead Sponsor:
Balaji Tamarappoo
Conditions:
Carotid Arteries
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 bein...
Detailed Description
The primary objectives of this exploratory study are: * To assess the uptake of \[F-18\] RGD-K5 by carotid plaque with PET/MRI imaging in participants prior to carotid endarterectomy and thereby dete...
Eligibility Criteria
Inclusion
- 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
- stroke due to atrial fibrillation,
- preexisting carotid stents in the artery of interest,
- renal dysfunction defined as glomerular filtration rate (GFR) \<40ml/min,
- allergy to gadolinium based contrast agents,
- Volunteers who have had four or more prior previous gadolinium contrast scans
- metal implants incompatible with MRI or other condition that prohibits MRI,
- pregnancy,
- inability to provide informed consent and
- age ≤18 years.
Key Trial Info
Start Date :
October 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2020
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03364270
Start Date
October 10 2018
End Date
May 31 2020
Last Update
August 9 2022
Active Locations (1)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048