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An exploratory study of [18F]AlF-NOTA-octreotide high resolution NeuroEXPLORER PET and MRI in carotid artery disease
EU CTIS ID: 2024-515636-77-00
What this study is testing
This single-center prospective study aims to evaluate the potential of [18F]AlF-OC high resolution NeuroEXPLORER PET and MRI in characterizing and quantifying carotid atherosclerotic disease in patients with recent stroke/TIA.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
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 an atherosclerotic plaque of ≥ 3 mm thickness in the ipsilateral internal carotid artery.. The stroke/TIA has occurred no more than 21 days prior to tracer administration.
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
- 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 analysis may be performed as part of the trial)
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 an atherosclerotic plaque of ≥ 3 mm thickness in the ipsilateral internal carotid artery.. The stroke/TIA has occurred no more than 21 days prior to tracer administration.
- 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
- 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 analysis may be performed as part of the trial)
- 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.
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.