[18F]AlF-NOTA-octreotide PET/MRI in Carotid Artery Disease
An Exploratory Study of [18F]AlF-NOTA-octreotide PET/MRI in Carotid Artery Disease
Universitaire Ziekenhuizen KU Leuven
24 participants
Mar 18, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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 Criteria8
- 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
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Interventions
Participants 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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07104487