CANF-Comb-II PET-MR in Atherosclerosis Multisite
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorWashington University School of Medicine
About this trial
The goal of this observational study is to learn more about plaque biology in asymptomatic carotid artery stenosis (ACAS) patients through imaging. The main questions it aims to answer are:
* To determine the ability of 64Cu-CANF-Comb positron emission tomography (PET) to risk stratify ACAS patients for stroke event, to include transient ischemic attack or remote ipsilateral intervention. * To further understand the role of Natriuretic Peptide Receptor C (NPRC) in the evolution of carotid atherosclerosis.
Participants will be asked to undergo a carotid PET-magnetic resonance imaging (MRI) examination to assess whether the carotid atherosclerosis uptake of 64Cu-CANF-Comb as measured by PET-MRI correlates with patient outcomes (stroke, transient ischemic attack, or remote ipsilateral intervention).
Eligibility criteria
Qualifiers
Adults, 18 years of age or older
Asymptomatic carotid artery stenosis patients who have undergone carotid Doppler/ultrasound imaging or other carotid imaging which have demonstrated a ≥ 60% diameter carotid artery stenosis.
The treating surgeon has planned either treatment with optimal medical therapy (OMT) alone, or OMT and carotid endarterectomy (CEA) surgical intervention.
Disqualifiers
Inability to receive and sign informed consent.
Patients with an unstable clinical condition that in the opinion of the Sponsor-Investigator or designee precludes participation in the study.
Inability to tolerate up to 60 minutes in a supine position with arms down at sides for PET-MR imaging.
Prior history of CEA or carotid artery stent procedure on the ipsilateral side.
Trial design
Treatments tested in this trial
- 64Cu-25%-CANF-Comb
- 64Cu-25%-CANF-Comb
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Washington University School of Medicine
Lead sponsor
Cedars-Sinai Medical Center
Collaborator
University of California, Santa Barbara
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov