[18F]AlF-NOTA-octreotide PET/MRI in Carotid Artery Disease
Belgium24 participantsStarted 2025-03-18
Plain-language summary
This clinical trial aims to evaluate whether \[¹⁸F\]AlF-OC PET/MRI 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.
Participants will undergo \[¹⁸F\]AlF-OC PET/MRI and will be followed via telephone interviews at 90 days, 1 year, and 3 years after their initial stroke or TIA.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Participant is aged over 18 years.
✓. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedure
✓. CT angiography imaging at baseline should be available as part of routine care
✓. 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/TIA has occurred no more than 21 days prior to tracer administration.
Exclusion criteria
✕. Female who is pregnant or breast-feeding
✕. Participants with a cardio-embolic stroke, small vessel stroke or other defined stroke etiology according to the TOAST classification (23)
✕. 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
✕. Participants treated with carotid endarterectomy or carotid artery stenting within the past year
✕. Subject has a contra-indication for or cannot tolerate MR scanning
✕. Subject has an impaired renal function estimated glomerular filtration rate (eGFR) \< 40 ml/min/1.73m² (the last known value may not date from more than 3 months prior to the study PET/MR; if not available a blood analysis may be performed as part of the trial)
✕. Concurrent treatment with corticosteroids and/or somatostatin analogues
✕. Subject is unwilling or unable to perform all of the study procedures, or is considered unsuitable in any way by the principal investigator