NCT07104487RecruitingPhase 2
[18F]AlF-NOTA-octreotide PET/MRI in Carotid Artery Disease
An Exploratory Study of [18F]AlF-NOTA-octreotide PET/MRI in Carotid Artery Disease
Source: ClinicalTrials.gov · Last updated 11 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 29 Jul 2025
- Start date
- Mar 2025
- Primary completion date
- Sept 2026
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Diseases
- Stroke
- NCT number
- NCT07104487
- EudraCT number
- 2024-515636-77
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 24
- From Mar 2025 to the primary completion date, Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Concurrent treatment with corticosteroids and/or somatostatin analogues
Other illness
- Participants with a cardio-embolic stroke, small vessel stroke or other defined stroke etiology according to the TOAST classification (23)
Lab values
- 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)
Other
- Female who is pregnant or breast-feeding
- Subject has a contra-indication for or cannot tolerate MR scanning
- Subject is unwilling or unable to perform all of the study procedures, or is considered unsuitable in any way by the principal investigator
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.