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

Phase 1

Completed

• Conditions: Carotid Atherosclerosis
• Interventions: Device: Cu[64]-25%-CANF-Comb PET-MR

• Registration Number: NCT02417688
• Lead Sponsor: Washington University School of Medicine

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.

Study Timeline

• Study Start: 2015-04-05
• Study First Submitted: 2015-04-11
• Study First Submitted QC: 2015-04-14
• Study First Posted: 2015-04-16
• Primary Completion: 2021-04-30
• Study Completion: 2021-04-30
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-13
• Last Update Posted: 2022-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Patients with carotid atherosclerosis
• Patients must be scheduled for carotid intervention (endarterectomy surgery)
• Signed informed consent.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cu[64]-25%-CANF-Comb PET-MR	Cu[64]-25%-CANF-Comb PET-MR	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

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Washington University in St.Louis; 🇺🇸 Saint Louis, Missouri, United States