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

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

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.

Study Overview

• Status: Completed
• Conditions: Carotid Atherosclerosis
• Intervention / Treatment: Device: Cu[64]-25%-CANF-Comb PET-MR

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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University in St.Louis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: Cu[64]-25%-CANF-Comb PET-MR; Single IV injection of a novel radiopharmaceutical for diagnostic imaging of atherosclerosis by PET-MR; Other Names: Cu[64]-25%-CANF-Comb

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Pamela K Wooderd, MD, Washington University School of Medicine

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2015
• Primary Completion (Actual): April 30, 2021
• Study Completion (Actual): April 30, 2021

Study Registration Dates

• First Submitted: April 11, 2015
• First Submitted That Met QC Criteria: April 14, 2015
• First Posted (Estimate): April 16, 2015

Study Record Updates

• Last Update Posted (Actual): October 17, 2022
• Last Update Submitted That Met QC Criteria: October 13, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: carotid atherosclerosis, PET imaging agent
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Carotid Artery Diseases; Atherosclerosis
• Other Study ID Numbers: 201409006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The investigators may share your images with other researchers. They may be doing research in areas similar to this research or in other unrelated areas. These researchers may be at Washington University, at other research centers and institutions, or industry sponsors of research. The investigators may also share your research data with large data repositories (a repository is a database of information) for broad sharing with the research community. If the individual research data is placed in one of these repositories only qualified researchers, who have received prior approval from individuals that monitor the use of the data, will be able to look at the information.
• IPD Sharing Time Frame: Beginning 3 months and ending 10 years following article publication.
• IPD Sharing Access Criteria: Proposals should be directly submitted to pwoodard@wustl.edu.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR