[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600976":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":30,"locations":38,"responsibleParty":55,"collaborators":24,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":24,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":24,"enrollmentInfo":66,"targetDuration":24,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":78,"overallStatus":40,"whyStopped":24,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Universitaire Ziekenhuizen KU Leuven","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Part A","EXPERIMENTAL","5 patients with ≥30% carotid artery stenosis on routine CT angiography (CTA) and a recent ischemic stroke in the supplying carotid artery territory will undergo \\[18F\\]AlF-OC PET\u002FMRI at 60, 120 and 180 minutes after tracer injection.",[13],"Drug: [18F]AlF-OC",{"label":15,"type":10,"description":16,"interventionNames":17},"Arm B","19 patients with ≥30% carotid artery stenosis on routine CTA and a recent ischemic stroke\u002FTIA in the supplying carotid artery territory will undergo \\[18F\\]AlF-OC PET\u002FMRI at the timepoint deemed optimal in part A of the study.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","[18F]AlF-OC","Participants received a single intravenous (IV) bolus injection of 4 MBq\u002Fkg \\[¹⁸F\\]AlF-OC (Al¹⁸F-1,4,7-triazacyclononane-1,4,7-triacetate-octreotide), followed by a flush with 0.9% NaCl.",[15,9],null,[26],{"name":27,"affiliation":28,"role":29},"Robin Lemmens, MD PhD","UZ Leuven","PRINCIPAL_INVESTIGATOR",[31,35],{"name":27,"role":32,"phone":33,"phoneExt":24,"email":34},"CONTACT","+32 16 34 42 80","robin.lemmens@uzleuven.be",{"name":36,"role":32,"phone":33,"phoneExt":24,"email":37},"Louise Maes, MD","louise.maes@uzleuven.be",[39],{"facility":28,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Leuven","Vlaams-Brabant","3000","Belgium","BE",{"type":47,"coordinates":48},"Point",[49,50],4.70093,50.87959,{"lat":50,"lon":49},[53,54],{"name":36,"role":32,"phone":33,"phoneExt":24,"email":37},{"name":27,"role":29,"phone":24,"phoneExt":24,"email":24},{"type":56,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100600976","phase-2-18falf-nota-octreotide-petmri-in-carotid-artery-disease-100600976",false,"NCT07104487","[18F]AlF-NOTA-octreotide PET\u002FMRI in Carotid Artery Disease","An Exploratory Study of [18F]AlF-NOTA-octreotide PET\u002FMRI in Carotid Artery Disease","Inclusion Criteria:\n\n1. Participant is aged over 18 years.\n2. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedure\n3. CT angiography imaging at baseline should be available as part of routine care\n4. Participant is diagnosed with a recent ischemic stroke or high-risk TIA (ABCD2 ≥ 4) in the carotid artery territory and ≥ 30% carotid artery stenosis. The stroke\u002FTIA has occurred no more than 21 days prior to tracer administration.\n\nExclusion Criteria:\n\n1. Female who is pregnant or breast-feeding\n2. Participants with a cardio-embolic stroke, small vessel stroke or other defined stroke etiology according to the TOAST classification (23)\n3. Participant has a previous or ongoing recurrent or chronic disease at high risk to interfere with the performance or evaluation of the trial, according to the judgment of the investigator\n4. Participants treated with carotid endarterectomy or carotid artery stenting within the past year\n5. Subject has a contra-indication for or cannot tolerate MR scanning\n6. Subject has an impaired renal function estimated glomerular filtration rate (eGFR) \\\u003C 40 ml\u002Fmin\u002F1.73m² (the last known value may not date from more than 3 months prior to the study PET\u002FMR; if not available a blood analysis may be performed as part of the trial)\n7. Concurrent treatment with corticosteroids and\u002For somatostatin analogues\n8. Subject is unwilling or unable to perform all of the study procedures, or is considered unsuitable in any way by the principal investigator","ALL","18 Years",{"count":67,"type":68},24,"ESTIMATED","INTERVENTIONAL",[71],"PHASE2","This clinical trial aims to evaluate whether \\[¹⁸F\\]AlF-OC PET\u002FMRI can characterize and quantify inflammation in carotid atherosclerotic plaques. The study will assess if tracer uptake in culprit and non-culprit carotid arteries, measured by standardized uptake values (SUV), is associated with future cerebrovascular events. Specifically, it will examine whether \\[¹⁸F\\]AlF-OC uptake predicts the risk of recurrent ipsilateral TIA, amaurosis fugax, stroke, or other vascular complications.\n\nParticipants will undergo \\[¹⁸F\\]AlF-OC PET\u002FMRI and will be followed via telephone interviews at 90 days, 1 year, and 3 years after their initial stroke or TIA.",[74,75,76,77],"Stroke (CVA) or TIA","Carotid Artery Plaque","Atherosclerosis Cardiovascular Disease","Carotid Arteriosclerosis",[79,80,81,82,83,84,85,86],"Internal Carotid Artery","Molecular Imaging","Atherosclerosis","Inflammation","PET\u002FMRI","SST2","[18F]AlF-NOTA-octreotide","Stroke\u002FTIA","2025-08-05",{"date":89,"type":90},"2025-08-11","ACTUAL",{"date":92,"type":90},"2025-03-18",{"date":94,"type":68},"2029-09",{"name":5,"class":6},1]