TRACER RGD-K5 Carotid Plaque Imaging Study
The purpose of this study is to investigate the abilityof the compound[F-18]RGD-K5, when used as a tracer during PET (positron emission tomography) imaging, to detect regions of unstable atherosclerotic plaque in the carotid artery of subjects being considered for carotid endarterectomy (CEA),and to confirm this ability through histological studies of samples of carotid artery plaques that will be collected during the planned carotid surgery.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||An Exploratory, Phase II, Open Label, Single-Center, Non-Randomized Study Of [F-18] RGD-K5 Positron Emission Tomography (PET) In Participants With Carotid Artery Stenosis|
- Target to background ratio (TBR) [ Time Frame: at time of PET imaging ] [ Designated as safety issue: No ]To assess uptake of [F-18]RGD-K5 by carotid plaque with PET/CT imaging (which will be expressed as a target to background ratio (TBR) of the standard uptake value (SUV)) in participants prior to carotid endarterectomy. The TBR of [F-18]RGD-K5 in the plaque will serve as a surrogate marker of plaque inflammation in participants being considered for carotid endarterectomy.
- Occurrence of adverse events [ Time Frame: at time of carotid endarterectomy ] [ Designated as safety issue: Yes ]In order to document that this tracer, [F-18]RGD-K5, is safe for clinical use in plaque imaging, patients will be contacted 24h after receiving the [F-18]RGD-K5. They will be questioned about any side effects or adverse events they might have experienced during that time after receiving the tracer.
|Study Start Date:||November 2013|
|Estimated Study Completion Date:||December 2019|
|Estimated Primary Completion Date:||December 2019 (Final data collection date for primary outcome measure)|
Experimental: PET imaging with [F-18] RDG-K5
This is an observational study of a group of individuals who all have carotid artery stenosis. The observation will be the measurement of [F-18]RGD-K5 uptake by the carotid artery plaque after intravenous administration of this radiolabeled tracer using PET imaging.
Drug: [F-18] RDG-K5
Up to fifteen (15) subjects with carotid stenosis >50% who are undergoing planned carotid endarterectomy will be imaged under PET with [F-18] RDG-K5
Patients will be chosen for the study based on presence of carotid artery stenosis ascertained by CTA and carotid artery ultrasound. Patients will receive and intravenous injection of the radiolabeled PET tracer,[F-18]RGD-K5, and will undergo PET imaging of their carotid arteries bilaterally. PET images will be analyzed to determine the standard uptake value (SUV) of [F-18]RGD-K5 uptake by the carotid artery plaque and this will be compared to the SUV of the background (blood pool in the aorta). This will be expressed as a target to background ratio (TBR). We expect to find a significant uptake of [F-18]RGD-K5 by carotid artery palque and we therefore expect to find a TBR that is significantly >1. We also expect to find that plaque from patients who show a TBR >1 will also be enriched for histologic markers for inflammation and angiogenesis.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01968226
|Contact: Balaji Tamarappoo, MD, PhDfirstname.lastname@example.org|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Contact: Balaji Tamarappoo, MD, PhD 216-444-6765 email@example.com|
|Principal Investigator: Balaji Tamarappoo, MD, PhD|
|Principal Investigator:||Balaji Tamarappoo, MD, PhD||The Cleveland Clinic|