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.
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.
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
Single group
[18F]AlF-OC
DrugParticipants received a single intravenous (IV) bolus injection of 4 MBq/kg \[¹⁸F\]AlF-OC (Al¹⁸F-1,4,7-triazacyclononane-1,4,7-triacetate-octreotide), followed by a flush with 0.9% NaCl.
Quantification of ICA [18F]AlF-OC uptake
Quantification of \[18F\]AlF-OC uptake in the culprit and non-culprit carotid artery by measures of standardized uptake value (SUV)
Recurrence of ipsilaterial TIA, stroke or amaurosis fugax
Recurrence of ipsilateral TIA, amaurosis fugax and stroke during follow-up
Recurrence of all stroke/TIA
Recurrence of all stroke/TIA during follow-up
Occurence of major adverse cardiovascular events (MACE)
Occurence of any vascular complication (stroke/TIA, myocardial infarction, cardiac arrest, hospitalisation for unstable angina or vascular death) during follow-up
Occurence of all-cause mortality
Occurence of all-cause mortality during follow-up
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