Imaging inflammation in neck artery plaques to study future stroke risk
Tests a PET scan tracer for plaque inflammation in people with stroke or TIA.
Plain-language title generated from the registry record
Registry title: [18F]AlF-NOTA-octreotide PET/MRI in Carotid Artery Disease
Key facts
- Where
- Leuven, BelgiumSee the site
- Phase
- Phase 2
Where in Belgium
- UZ LeuvenLeuven, BelgiumTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Universitaire Ziekenhuizen KU Leuven
- Trial code
- NCT07104487
- Record updated
- 11 August 2025
- Original description
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.Read full original descriptionShow less
An Exploratory Study of [18F]AlF-NOTA-octreotide PET/MRI in Carotid Artery Disease
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.
Inclusion: 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: 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; Concurrent treatment with corticosteroids and/or somatostatin analogues; Participants with a cardio-embolic stroke, small vessel stroke or other defined stroke etiology according to the TOAST classification (23); 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); Female who is pregnant or breast-feeding; Subject has a contra-indication for or cannot tolerate MR scanning; Subject is unwilling or unable to perform all of the study procedures, or is considered unsuitable in any way by the principal investigator.