Carotid Atherosclerosis
Conditions
Keywords
carotid atherosclerosis, PET imaging agent
Brief summary
To demonstrate feasibility of imaging Cu\[64\]-25%-CANF-Comb uptake in the atherosclerosis of the carotid artery of patients for whom carotid artery endarterectomy surgery is planned in comparison to the carotid artery for which intervention is not planned.
Detailed description
This study is a single center, open-label baseline controlled imaging study designed to demonstrate feasibility of PET imaging of radiopharmaceutical nanoparticle Cu\[64\]-25%CANF-Comb uptake by PET-MR. Patients will undergo Cu\[64\]-25%CANF-Comb PET-MR imaging of both carotid arteries. Both carotid arteries will be imaged at the same time. We hope to demonstrate differences in PET SUV (Standardized Uptake Value) in the significantly atherosclerotic artery in patients who will be going to carotid endarterectomy surgery in comparison to the PET SUV in the artery that is not significantly diseased (ie; the artery that will not undergo surgery) . We also will determine whether PET SUV of the Cu\[64\]-25%CANF-Comb by the plaque correlates to the American Heart Association classifications of atherosclerosis and tissue presence of NPR-C in the ex vivo carotid endarterectomy specimen post surgery as measured by RT-PCR.
Interventions
DEVICECu[64]-25%-CANF-Comb PET-MR
Single IV injection of a novel radiopharmaceutical for diagnostic imaging of atherosclerosis by PET-MR
Sponsors
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with carotid atherosclerosis * Patients must be scheduled for carotid intervention (endarterectomy surgery) * Signed informed consent.
Exclusion criteria
* Unstable clinical conditions * Pregnancy and lactation * Inability to lie still for up to 60 min with arms down at sides for PET-MR imaging * Unwilling to comply with study procedures and unavailable for the duration of the study. * Pacemakers, brain aneurysm clip, shrapnel and other typical contraindications for MRI imaging. * Inability to provide written informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PET SUV (Standardized Uptake Value) | 22-26 hours | Difference in SUV between the carotid with atherosclerosis (carotid artery to be undergo surgery) and the carotid artery without significant disease (artery for which surgery is not planned). |
Countries
United States
Outcome results
None listed