Ireland
--:--IST
Recruiting Phase 2

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

NCT07104487 · tracked via the Priya Life Science Belgium tracker
Phase
Phase 2
Started
2025-03-18
Last updated
2025-08-11

Condition(s) studied

Stroke (CVA) or TIACarotid Artery PlaqueAtherosclerosis Cardiovascular DiseaseCarotid Arteriosclerosis

Investigational drug(s) / intervention(s)

[18F]AlF-OC

[18F]AlF-OC: 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.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Quantification of ICA [18F]AlF-OC uptake — 1 hour post-injection
    Quantification of \[18F\]AlF-OC uptake in the culprit and non-culprit carotid artery by measures of standardized uptake value (SUV)

Trial sites (1)

FacilityCityRegionStatus
UZ Leuven Leuven Vlaams-Brabant Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07104487 on ClinicalTrials.gov ↗ ← All trials in Belgium