PET/MRI with [18F]AlF-NOTA-octreotide to image inflammation in carotid artery plaque
An Exploratory Study of [18F]AlF-NOTA-octreotide PET/MRI in Carotid Artery Disease
This will test whether [18F]AlF-OC PET/MRI can measure inflammation in carotid plaques and help predict recurrent stroke or TIA in people who recently had a carotid-territory stroke or high-risk TIA with at least 30% carotid stenosis.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven, Vlaams-Brabant) |
| Trial ID | NCT07104487 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults (≥18) who had an ischemic stroke or high-risk TIA in the carotid territory within 21 days and have ≥30% ipsilateral carotid stenosis on CTA and can undergo PET/MRI.
Not a fit: Patients with cardioembolic or small-vessel stroke etiologies, pregnant or breastfeeding individuals, those who cannot undergo PET/MRI, or those who already had carotid surgery are unlikely to benefit from this imaging approach.
Why it matters
Potential benefit: If successful, this imaging approach could help identify inflamed, high-risk carotid plaques and improve decisions about which patients need more aggressive treatment to prevent recurrent stroke.
How similar studies have performed: Other PET tracers targeting somatostatin receptors and inflammation (e.g., 68Ga-DOTATATE) have shown promise for imaging plaque inflammation, but use of [18F]AlF-OC specifically for carotid risk prediction is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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 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 this trial is running
Leuven, Vlaams-Brabant
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.