Prospective comparison of [18F]AlF-NOTA-octreotide PET/MRI to [68Ga]Ga-DOTATATE PET/CT in neuroendocrine tumor patients.
Lennert Boeckxstaens, Elin Pauwels, Vincent Vandecaveye...
https://pubmed.ncbi.nlm.nih.gov/37261615Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID07104487
An Exploratory Study of [18F]AlF-NOTA-octreotide PET/MRI in Carotid Artery Disease
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2025-08-11
24
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of [18F]AlF-NOTA-octreotide PET/MRI to study inflammation in carotid artery plaques in patients who recently had a stroke or transient ischemic attack (TIA) in the carotid artery area. This study aims to see if the tracer uptake in affected and unaffected carotid arteries can predict future cerebrovascular events such as recurrent TIA, stroke, or other vascular problems. The trial is conducted as a Phase 2 study at University Hospitals Leuven and focuses on patients with at least 30% stenosis in the carotid artery. Participants receive a single intravenous injection of the radioactive tracer [18F]AlF-OC, dosed at 4 MBq/kg, followed by a saline flush. The study has two parts: in the first, five patients undergo PET/MRI scans at 60, 120, and 180 minutes after injection to refine the imaging protocol. In the second part, nineteen patients receive PET/MRI at the optimal time point identified earlier. Both the symptomatic (culprit) and non-symptomatic carotid arteries are scanned. Participants will have a screening and baseline assessment, followed by the PET/MRI imaging visit. They will be contacted by telephone for follow-up interviews at 90 days, 1 year, and 3 years after their initial stroke or TIA. Researchers will measure the standardized uptake values (SUV) of the tracer in the carotid arteries as the primary outcome. Secondary outcomes include the prediction of recurrent cerebrovascular events, major cardiovascular events, and overall mortality during the three-year follow-up period.
CONDITIONS
Brief Title
[18F]AlF-NOTA-octreotide PET/MRI in Carotid Artery Disease
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Participant is aged over 18 years.
- Voluntary written informed consent has been obtained.
- CT angiography imaging at baseline is available as part of routine care.
- Diagnosed with a recent ischemic stroke or high-risk TIA (ABCD2 64) in the carotid artery territory.
- At least 30% carotid artery stenosis.
- Stroke or TIA occurred no more than 21 days before tracer administration.
You will not qualify if you...
- Female who is pregnant or breastfeeding.
- Cardio-embolic stroke, small vessel stroke, or other defined stroke etiology per TOAST classification.
- Previous or ongoing chronic disease that could interfere with the trial.
- Carotid endarterectomy or carotid artery stenting within the past year.
- Contraindication or inability to tolerate MR scanning.
- Impaired kidney function with eGFR less than 40 ml/min/1.73m.
- Concurrent treatment with corticosteroids or somatostatin analogues.
- Unwilling or unable to complete all study procedures or deemed unsuitable by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Diagnostic Evaluation
Duration - Single day
Participants receive an intravenous injection of the imaging agent followed by PET/MRI scans to characterize carotid artery disease.
1 imaging visit (in-person)
Long-term Monitoring
Duration - Up to 3 years after the initial stroke
Participants are followed up by telephone interviews to assess clinical outcomes and recurrence of vascular events.
3 follow-up visits by telephone at 90 days, 1 year, and 3 years after the initial stroke
Trial Site Locations
Total: 1 location
1
UZ Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
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Research Team
R
Robin Lemmens, MD PhD
L
Louise Maes, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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Published Research Related To This Trial
[18F]AlF-NOTA-octreotide PET imaging: biodistribution, dosimetry and first comparison with [68Ga]Ga-DOTATATE in neuroendocrine tumour patients.
Elin Pauwels, Frederik Cleeren, Térence Tshibangu...
https://pubmed.ncbi.nlm.nih.gov/32617641Novel Targets for Molecular Imaging of Inflammatory Processes of Carotid Atherosclerosis: A Systematic Review.
Louise Maes, Louis Versweyveld, Nicholas R Evans...
https://pubmed.ncbi.nlm.nih.gov/37996309