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
1 other identifier
interventional
44
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Apr 2015
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 5, 2015
CompletedFirst Submitted
Initial submission to the registry
April 11, 2015
CompletedFirst Posted
Study publicly available on registry
April 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2021
CompletedOctober 17, 2022
October 1, 2022
6.1 years
April 11, 2015
October 13, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Cu[64]-25%-CANF-Comb PET-MR
EXPERIMENTALSingle 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
Interventions
Single IV injection of a novel radiopharmaceutical for diagnostic imaging of atherosclerosis by PET-MR
Eligibility Criteria
You may qualify if:
- Patients with carotid atherosclerosis
- Patients must be scheduled for carotid intervention (endarterectomy surgery)
- Signed informed consent.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington University in St.Louis
St Louis, Missouri, 63110, United States
Related Publications (2)
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.
PMID: 22049461BACKGROUNDLiu 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.
PMID: 20008978BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pamela K Wooderd, MD
Washington University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2015
First Posted
April 16, 2015
Study Start
April 5, 2015
Primary Completion
April 30, 2021
Study Completion
April 30, 2021
Last Updated
October 17, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, CSR
- Time Frame
- Beginning 3 months and ending 10 years following article publication.
- Access Criteria
- Proposals should be directly submitted to pwoodard@wustl.edu.
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.