PET Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis

The Washington University

Status and phase: Completed; Phase 1

Conditions: Carotid Atherosclerosis

Treatments: Device: Cu[64]-25%-CANF-Comb PET-MR

Study type: Interventional

Funder types: Other

Identifiers

NCT02417688

201409006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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44 participants in 1 patient group

Cu[64]-25%-CANF-Comb PET-MR

Experimental group

Description:

Single IV injection of 4-8 mCi of Cu\[64\]-25%-CANF-Comb with a mass no more than 100 μgrams followed by PET-MR Imaging

Treatment:

Device: Cu[64]-25%-CANF-Comb PET-MR