Actively Recruiting
PET-MR Imaging of Natriuretic Peptide Receptor C in Carotid Atherosclerosis Using Cu[64]-25%-CANF-Comb-II
Led by Washington University School of Medicine · Updated on 2026-03-23
80
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
W
Washington University School of Medicine
Lead Sponsor
C
Cedars-Sinai Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying plaque biology in patients with asymptomatic carotid artery stenosis (ACAS) using advanced imaging techniques. This observational study aims to assess whether 64Cu-CANF-Comb positron emission tomography (PET) combined with magnetic resonance imaging (MRI) can help predict stroke risk or related events in ACAS patients. The study also seeks to better understand the role of Natriuretic Peptide Receptor C (NPRC) in the progression of carotid artery atherosclerosis. Participants will receive an intravenous injection of 2-6 milliCuries of the 64Cu-25%-CANF-Comb radiotracer approved for investigational use. They will undergo a carotid PET/MRI scan 12 to 24 hours after injection to evaluate plaque uptake. Patients treated with optimal medical therapy (OMT) alone will have a repeat PET/MRI 12 to 18 months later or sooner if symptoms develop, while those treated with OMT and carotid endarterectomy (CEA) will have imaging only once. The study enrolls 80 subjects with carotid artery narrowing of 60% or more. During the study, participants will have baseline assessments including physical exams, blood and urine tests, and vital sign measurements. Researchers will collect medication and risk factor information, and follow up by phone every three months for up to four years to monitor for stroke, transient ischemic attack, or carotid interventions. Imaging results and clinical outcomes will help evaluate the potential of PET/MRI to stratify stroke risk and understand carotid plaque biology over time.
CONDITIONS
Brief Title
CANF-Comb-II PET-MR in Atherosclerosis Multisite
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years of age or older
- Diagnosed with asymptomatic carotid artery stenosis showing 60% or greater narrowing by ultrasound, Doppler, or other carotid imaging
- Planned treatment with optimal medical therapy alone or combined with carotid endarterectomy surgery
You will not qualify if you...
- Unable to give and sign informed consent
- Unstable clinical condition deemed unsuitable for study participation by investigator
- Unable to lie still in a supine position for up to 60 minutes for PET-MR imaging
- Prior carotid endarterectomy or carotid stent procedure on the same side
- History of transient ischemic attack or stroke within the last 6 months
- Unable or unwilling to comply with study procedures or be available for the study duration
- Contraindications to MRI such as pacemaker, brain aneurysm clips, shrapnel, or severe claustrophobia
- Currently pregnant or breastfeeding; females of childbearing potential must have a negative pregnancy test or be post-menopausal or surgically sterile
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single time point 12 to 24 hours after injection
Participants undergo carotid PET/MRI imaging after receiving an intravenous injection of the 64Cu-25%-CANF-Comb radiotracer to assess carotid artery atherosclerosis.
1 imaging visit (in-person)
Duration - Up to 4 years
Participants are followed with telephone calls every 3 months to monitor for ischemic cerebrovascular events or carotid interventions. Participants treated with optimal medical therapy alone may undergo repeat PET/MRI imaging at 12 to 18 months or earlier if symptoms develop.
Telephone follow-up every 3 months; 1 to 2 imaging visits depending on treatment
Trial Site Locations
Total: 2 locations
1
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
2
Washington University in St. Louis
St Louis, Missouri, United States, 63130-2344
Actively Recruiting
Research Team
M
Molly Mohrman
P
Pamela Woodard, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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