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

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ClinicalTrials.gov Identifier: NCT02417688
Recruitment Status : Completed
First Posted : April 16, 2015
Last Update Posted : October 17, 2022
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Study Description
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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.

Condition or disease Intervention/treatment Phase
Carotid Atherosclerosis Device: Cu[64]-25%-CANF-Comb PET-MR Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: PET-MR Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis With [64]Cu-25%CANF-Comb
Actual Study Start Date : April 5, 2015
Actual Primary Completion Date : April 30, 2021
Actual Study Completion Date : April 30, 2021

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Arms and Interventions
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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 Name: Cu[64]-25%-CANF-Comb


Outcome Measures
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Primary Outcome Measures :
  1. PET SUV (Standardized Uptake Value) [ Time Frame: 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).


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02417688


Locations
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United States, Missouri
Washington University in St.Louis
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Pamela K Wooderd, MD Washington University School of Medicine
More Information
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Publications:

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02417688    
Other Study ID Numbers: 201409006
First Posted: April 16, 2015    Key Record Dates
Last Update Posted: October 17, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Beginning 3 months and ending 10 years following article publication.
Access Criteria: Proposals should be directly submitted to pwoodard@wustl.edu.
Keywords provided by Washington University School of Medicine:
carotid atherosclerosis, PET imaging agent
Additional relevant MeSH terms:
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Carotid Artery Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
 Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases