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

NCT ID: NCT02417688

Last Updated: 2022-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-05
• Study Completion Date: 2021-04-30

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.

Conditions

Carotid Atherosclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

Single IV injection of a novel radiopharmaceutical for diagnostic imaging of atherosclerosis by PET-MR

Interventions

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

Single IV injection of a novel radiopharmaceutical for diagnostic imaging of atherosclerosis by PET-MR

Intervention Type: DEVICE

Other Intervention Names

Cu[64]-25%-CANF-Comb

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pamela K Wooderd, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University in St.Louis

St Louis, Missouri, United States

Countries

United States

References

Liu Y, Pressly ED, Abendschein DR, Hawker CJ, Woodard GE, Woodard PK, Welch MJ. Targeting angiogenesis using a C-type atrial natriuretic factor-conjugated nanoprobe and PET. J Nucl Med. 2011 Dec;52(12):1956-63. doi: 10.2967/jnumed.111.089581. Epub 2011 Nov 2.

Reference Type: BACKGROUND

PMID: 22049461 (View on PubMed)

Liu Y, Abendschein D, Woodard GE, Rossin R, McCommis K, Zheng J, Welch MJ, Woodard PK. Molecular imaging of atherosclerotic plaque with (64)Cu-labeled natriuretic peptide and PET. J Nucl Med. 2010 Jan;51(1):85-91. doi: 10.2967/jnumed.109.066977. Epub 2009 Dec 15.

Reference Type: BACKGROUND

PMID: 20008978 (View on PubMed)

Other Identifiers

201409006

Identifier Type: -

Identifier Source: org_study_id