[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100503691":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":27,"centralContacts":31,"locations":40,"responsibleParty":72,"collaborators":74,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":10,"eligibilityCriteria":88,"healthyVolunteers":84,"sex":89,"minAge":90,"maxAge":10,"enrollmentInfo":91,"targetDuration":10,"studyType":94,"phases":10,"briefSummary":95,"conditions":96,"keywords":100,"overallStatus":43,"whyStopped":10,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Washington University School of Medicine","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients treated with Optimal Medical Therapy (OMT) alone.",null,"Asymptomatic carotid artery stenosis (ACAS) patients with known carotid artery atherosclerosis by ultrasound\u002FDoppler or other carotid imaging ≥ 60% diameter stenosis who are clinically referred for OMT alone.",[13],"Drug: 64Cu-25%-CANF-Comb",{"label":15,"type":10,"description":16,"interventionNames":17},"Patients treated with OMT and carotid endarterectomy (CEA).","Asymptomatic carotid artery stenosis (ACAS) patients with known carotid artery atherosclerosis by ultrasound\u002FDoppler or other carotid imaging ≥ 60% diameter stenosis who are clinically referred for OMT and CEA.",[13],[19,24],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"DRUG","64Cu-25%-CANF-Comb","Patients 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\u002FMR 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.",[9],{"type":20,"name":21,"description":25,"armGroupLabels":26,"otherNames":10},"Patients treated with OMT and CEA will receive an intravenous injection of 2-6 mCi of 64Cu-25%-CANF-Comb radiotracer for PET\u002FMR imaging at the initial imaging visit.",[15],[28],{"name":29,"affiliation":5,"role":30},"Pamela Woodard, MD","PRINCIPAL_INVESTIGATOR",[32,37],{"name":33,"role":34,"phone":35,"phoneExt":10,"email":36},"Molly Mohrman","CONTACT","314-747-4633","mohrmanm@wustl.edu",{"name":29,"role":34,"phone":38,"phoneExt":10,"email":39},"314-362-7100","woodardp@wustl.edu",[41,59],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Cedars Sinai Medical Center","RECRUITING","Los Angeles","California","90048","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-118.24368,34.05223,{"lat":53,"lon":52},[56],{"name":57,"role":34,"phone":10,"phoneExt":10,"email":58},"Yibin Xie, Ph.D","Yibin.Xie@cshs.org",{"facility":60,"status":43,"city":61,"state":62,"zip":63,"country":47,"countryCode":48,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Washington University in St. Louis","St Louis","Missouri","63130-2344",{"type":50,"coordinates":65},[66,67],-90.19789,38.62727,{"lat":67,"lon":66},[70],{"name":71,"role":34,"phone":10,"phoneExt":10,"email":39},"Pamela K Woodard, MD",{"type":30,"investigatorFullName":29,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"HM Wilson Professor of Radiology",[75,77,79],{"name":76,"class":6},"Cedars-Sinai Medical Center",{"name":78,"class":6},"University of California, Santa Barbara",{"name":80,"class":81},"National Heart, Lung, and Blood Institute (NHLBI)","NIH","100503691","canf-comb-ii-pet-mr-in-atherosclerosis-multisite-100503691",false,"NCT05838547","CANF-Comb-II PET-MR in Atherosclerosis Multisite","PET-MR Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis With Cu[64]-25%-CANF-Comb-II","Inclusion Criteria:\n\n* Adults, 18 years of age or older\n* Asymptomatic carotid artery stenosis patients who have undergone carotid Doppler\u002Fultrasound imaging or other carotid imaging which have demonstrated a ≥ 60% diameter carotid artery stenosis.\n* The treating surgeon has planned either treatment with optimal medical therapy (OMT) alone, or OMT and carotid endarterectomy (CEA) surgical intervention.\n\nExclusion Criteria:\n\n* Inability to receive and sign informed consent.\n* Patients with an unstable clinical condition that in the opinion of the Sponsor-Investigator or designee precludes participation in the study.\n* Inability to tolerate up to 60 minutes in a supine position with arms down at sides for PET-MR imaging.\n* Prior history of CEA or carotid artery stent procedure on the ipsilateral side.\n* Past medical history of TIA or stroke within the last 6 months.\n* Unwilling to comply with study procedures and\u002For unable to be available for the duration of the study outlined in the protocol.\n* Contraindications to MR imaging (pacemaker, brain aneurysm clips, shrapnel, claustrophobia, etc.).\n* Currently pregnant or lactating. All female subjects of childbearing potential must have a documented negative pregnancy test (serum or urine hCG) performed within 24 hours immediately prior to the administration of 64Cu-25%-CANF-Comb or documented post-menopausal defined as the cessation of menses for ≥ 12 months or documentation of having a bilateral oophorectomy and\u002For hysterectomy.","ALL","18 Years",{"count":92,"type":93},80,"ESTIMATED","OBSERVATIONAL","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:\n\n* 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.\n* To further understand the role of Natriuretic Peptide Receptor C (NPRC) in the evolution of carotid atherosclerosis.\n\nParticipants 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).",[97,98,99],"Carotid Atherosclerosis","Asymptomatic Carotid Artery Stenosis","Carotid Artery Atheroma",[101,102,103,104],"Stroke","TIA","Vascular Disease","Cardiovascular Disease","2026-03-19",{"date":107,"type":108},"2026-03-23","ACTUAL",{"date":110,"type":108},"2023-03-21",{"date":112,"type":93},"2027-05-31",{"name":5,"class":6},2]