NCT01968226

TRACER RGD-K5 Carotid Plaque Imaging Study

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the ability of 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.

Detailed description

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). Investigators expect to find a significant uptake of \[F-18\]RGD-K5 by carotid artery palque and investigators therefore expect to find a TBR that is significantly \>1. Investigators also expect to find that plaque from patients who show a TBR \>1 will also be enriched for histologic markers for inflammation and angiogenesis.

Conditions

• Carotid Artery Disease
• Carotid Stenosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2013-11-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2013-10-23
• Last updated: 2017-09-12
• Results posted: 2017-08-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study