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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 : Suspended (temp suspend due to covid)
First Posted : April 16, 2015
Last Update Posted : May 11, 2020
Sponsor:
Information provided by (Responsible Party):
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.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 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 2015
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine


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




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).



Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

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
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: May 11, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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