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

Primary Purpose

Carotid Atherosclerosis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cu[64]-25%-CANF-Comb PET-MR
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Carotid Atherosclerosis focused on measuring carotid atherosclerosis, PET imaging agent

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Washington University in St.Louis

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
April 11, 2015
Last Updated
October 13, 2022
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02417688
Brief Title
PET Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis
Official Title
PET-MR Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis With [64]Cu-25%CANF-Comb
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
April 5, 2015 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
April 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Atherosclerosis
Keywords
carotid atherosclerosis, PET imaging agent

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cu[64]-25%-CANF-Comb PET-MR
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Cu[64]-25%-CANF-Comb PET-MR
Other Intervention Name(s)
Cu[64]-25%-CANF-Comb
Intervention Description
Single IV injection of a novel radiopharmaceutical for diagnostic imaging of atherosclerosis by PET-MR
Primary Outcome Measure Information:
Title
PET SUV (Standardized Uptake Value)
Description
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).
Time Frame
22-26 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pamela K Wooderd, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University in St.Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
22049461
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.
Results Reference
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PubMed Identifier
20008978
Citation
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.
Results Reference
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PET Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis

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