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New treatment option for Stroke (CVA) or TIA
Official title [18F]AlF-NOTA-octreotide PET/MRI in Carotid Artery Disease
ClinicalTrials.gov ID: NCT07104487
What this study is testing
What is [18F]AlF-OC?
[18F]AlF-OC is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for stroke (cva) or tia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 3 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- Female who is pregnant or breast-feeding
- Participants with a cardio-embolic stroke, small vessel stroke or other defined stroke etiology according to the TOAST classification (23)
- Participant has a previous or ongoing recurrent or chronic disease at high risk to interfere with the performance or evaluation of the trial...
- Participants treated with carotid endarterectomy or carotid artery stenting within the past year
- Subject has a contra-indication for or cannot tolerate MR scanning
- 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...
See the full eligibility criteria
- 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...
- Female who is pregnant or breast-feeding
- Participants with a cardio-embolic stroke, small vessel stroke or other defined stroke etiology according to the TOAST classification (23)
- 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
- Subject has a contra-indication for or cannot tolerate MR scanning
- 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...
- Concurrent treatment with corticosteroids and/or somatostatin analogues
- Subject is unwilling or unable to perform all of the study procedures, or is considered unsuitable in any way by the principal investigator
The study team makes the final eligibility decision.
Where it's taking place
- Leuven, Vlaams-Brabant, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 3 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leuven, Vlaams-Brabant, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.