PET/MRI with [18F]AlF-NOTA-octreotide to image inflammation in carotid artery plaque

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center, phase 2 interventional study uses [18F]AlF-OC PET/MRI to quantify tracer uptake in culprit and non-culprit carotid atherosclerotic plaques by standardized uptake value (SUV). An initial optimization phase will image five patients at multiple timepoints after injection to determine the optimal imaging window, followed by imaging of the remaining participants at the chosen timepoint after a 4 MBq/kg injection. Participants undergo a baseline assessment and one PET/MRI visit, with clinical follow-up by telephone at 90 days, 1 year, and 3 years to capture recurrent ipsilateral TIA, amaurosis fugax, stroke, or other vascular events. The primary outcome is measurement of [18F]AlF-OC uptake in the carotid arteries and its association with future cerebrovascular events.

Why it matters

Who can join: the full rules

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 stenting within the past year
5. Subject has a contra-indication for or cannot tolerate MR scanning
6. 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)
7. Concurrent treatment with corticosteroids and/or somatostatin analogues
8. Subject is unwilling or unable to perform all of the study procedures, or is considered unsuitable in any way by the principal investigator

Where it's running

• UZ Leuven
  Leuven, Vlaams-Brabant, Belgium Recruiting

Study contacts

• Principal investigator: Robin Lemmens, MD PhD — UZ Leuven
• Study coordinator: Robin Lemmens, MD PhD
• Email: robin.lemmens@uzleuven.be
• Phone: +32 16 34 42 80

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.