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

Carotid Atherosclerosis Clinical Trial

Official title:

PET-MR Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis With [64]Cu-25%CANF-Comb

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02417688
• Other study ID #: 201409006
• Status: Completed
• Phase: Phase 1
• Start date: April 5, 2015
• Est. completion date: April 30, 2021

Study information

• Verified date: October 2022
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atherosclerosis
• Carotid Artery Diseases
• Carotid Atherosclerosis

Intervention

Device:
• Cu[64]-25%-CANF-Comb PET-MR
Single IV injection of a novel radiopharmaceutical for diagnostic imaging of atherosclerosis by PET-MR

Locations

Country	Name	City	State
United States	Washington University in St.Louis	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PET SUV (Standardized Uptake Value)	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).	22-26 hours