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
This trial does not accept healthy volunteersQualifiers
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 population
Individuals ≥18 years of age with asymptomatic carotid artery stenosis.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
64Cu-25%-CANF-Comb
DrugPatients treated with OMT alone that are not treated with CEA will receive an intravenous injection of 2-6 mCi of 64Cu-25%-CANF-Comb radiotracer for PET/MR imaging at the initial imaging visit and at 12-18 months, or earlier if they develop symptoms. While 12-18 months is the preferred window for repeat imaging, if imaging during this time frame is not achievable, the patient may return anytime throughout the remainder of the study.
64Cu-25%-CANF-Comb
DrugPatients treated with OMT and CEA will receive an intravenous injection of 2-6 mCi of 64Cu-25%-CANF-Comb radiotracer for PET/MR imaging at the initial imaging visit.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Patients treated with Optimal Medical Therapy (OMT) alone.1 intervention
Group B: Patients treated with OMT and carotid endarterectomy (CEA).1 intervention
Trial outcomes
Primary outcomes
1
Number of patients reporting ipsilateral ischemic cerebrovascular event (TIA, stroke) or remote ipsilateral carotid intervention
Patients will be contacted every 3 months after PET/MR imaging to assess for interval ipsilateral ischemic cerebrovascular event. In patients treated with OMT, it is anticipated that higher 64Cu-CANF-Comb PET signal (SUV) will correlate with increased ipsilateral ischemic cerebrovascular event (TIA, stroke) or remote ipsilateral carotid intervention (CEA surgery or stent placement); PET signal (SUV) will be assessed as a marker of risk for event in comparison to anatomic features of vulnerable plaque on MRI, with the goal of determining 64Cu-CANF-Comb PET signal above which suggests ACAS at higher risk.
Time frame
Through study completion, up to 4 years.Secondary outcomes
1
Changes in 64Cu-CANF-Comb PET signal - OMT
Patients treated with OMT will be imaged at baseline and at 12-18 months, or earlier if they develop symptoms, to determine interval change in 64Cu-CANF-Comb PET signal (SUV) over time. While 12-18 months is the preferred window for repeat imaging, if imaging during this time frame is not achievable, the patient may return anytime throughout the remainder of the study.
Time frame
12-18 months (preferred); through study completion, up to 4 years.2
PET signal relative to presence of targeted receptor, NPR-C and histopathological features of plaque vulnerability - CEA surgery as Treatment
In patients who initially undergo CEA, PET signal (SUV) will be compared to ex vivo plaque vulnerability and NPRC cellular distribution to facilitate understanding of gene expression using immunohistochemistry (IHC) and cell lineage/origin through single cell RNA (scRNA)/cellular indexing of transcriptomes and epitopes (CITE)-seq.
Time frame
Immediately after surgery.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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