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Recruiting Phase 2 NCT07104487

[18F]AlF-NOTA-octreotide PET/MRI in Carotid Artery Disease

Trial Parameters

Condition Stroke (CVA) or TIA
Sponsor Universitaire Ziekenhuizen KU Leuven
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 24
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-03-18
Completion 2026-09
Interventions
[18F]AlF-OC

Brief 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 Criteria

Inclusion Criteria: 1. Participant is aged over 18 years. 2. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedure 3. CT angiography imaging at baseline should be available as part of routine care 4. 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: 1. Female who is pregnant or breast-feeding 2. Participants with a cardio-embolic stroke, small vessel stroke or other defined stroke etiology according to the TOAST classification (23) 3. 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 4. Participants treated with carotid endarterectomy or carotid artery stentin

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