Stroke (CVA) or TIAPhase 2NCT07104487
[18F]AlF-NOTA-octreotide PET/MRI in Carotid Artery Disease
A Phase 2 study testing [18F]AlF-OC in people with Stroke (CVA) or TIA and Carotid Artery Plaque, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke (CVA) or TIA, Carotid Artery Plaque, Atherosclerosis Cardiovascular Disease
- What is being tested?
- [18F]AlF-OC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBelgium
- Study dates
- 18 Mar 2025to Sep 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven, Vlaams-Brabant, 3000
Louise Maes, MD, +32 16 34 42 80, louise.maes@uzleuven.be
Robin Lemmens, MD PhD
About this study
Official title: An Exploratory Study of [18F]AlF-NOTA-octreotide PET/MRI in Carotid Artery Disease
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.
Read the detailed description
Our study aims to assess the potential of molecular imaging with [18F]AlF-OC PET/MRI to characterize and quantify carotid atherosclerotic disease manifestations in patients with a recent stroke/TIA in the carotid artery territory. Eligible patients should have ≥30% stenosis in the ipsilateral carotid artery, as diagnosed by routine CTA. Additionally, we will evaluate the role of [18F]AlF-OC PET/MRI in risk stratification for recurrent events of patients with carotid artery stenosis and recent TIA/stroke.
This study is a single center study conducted at University Hospitals Leuven in Belgium. In a first part of this study, five patients will undergo serial [18F]AlF-OC PET/MRI at 60, 120 and 180 minutes after injection of 4 MBq/kg [18F]AlF-OC for protocol optimization and methodology refinement. In the second part of this trial, patients will undergo [18F]AlF-OC PET/MRI at the timepoint deemed as optimal based on the findings from the first part. All subjects will be required to undergo a screening and baseline assessment, an imaging visit ([18F]AlF-OC PET/MRI) and three follow-up visits (telephone interview at 90 days, 1 year and 3 years after the initial stroke onset). The primary outcome is the quantification of [18F]AlF-OC uptake in the carotid artery by measures of standardized uptake value (SUV). For every patient, both culprit (recent symptomatic event in ipsilateral carotid artery territory) and non-culprit (recent symptomatic event in the contralateral carotid artery territory) carotid arteries will be assessed. Secondary outcomes include the predictive value of baseline plaque SUV and TBR for the recurrence of ipsilateral TIA, amaurosis fugax and stroke during 3 years follow-up, the recurrence of all stroke/TIA, the occurrence of any vascular complication (stroke/TIA, myocardial infarction, cardiac arrest, hospitalisation for unstable angina or vascular death) and the occurrence of all-cause mortality.
- Conditions
- Stroke (CVA) or TIA, Carotid Artery Plaque, Atherosclerosis Cardiovascular Disease, Carotid Arteriosclerosis
- Being tested
- [18F]AlF-OC
- Keywords
- Internal Carotid Artery, Molecular Imaging, Atherosclerosis, Inflammation, PET/MRI, SST2, [18F]AlF-NOTA-octreotide, Stroke/TIA
- Medical subject headings
- Stroke, Carotid Stenosis, Carotid Artery Diseases, Atherosclerosis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]AlF-OCDrug
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 group | Role | What they receive |
|---|---|---|
| Part A | Experimental | 5 patients with ≥30% carotid artery stenosis on routine CT angiography (CTA) and a recent ischemic stroke in the supplying carotid artery territory will undergo [18F]AlF-OC PET/MRI at 60, 120 and 180 minutes after tracer injection. Receives: Drug: [18F]AlF-OC |
| Arm B | Experimental | 19 patients with ≥30% carotid artery stenosis on routine CTA and a recent ischemic stroke/TIA in the supplying carotid artery territory will undergo [18F]AlF-OC PET/MRI at the timepoint deemed optimal in part A of the study. Receives: Drug: [18F]AlF-OC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of ICA [18F]AlF-OC uptake
Quantification of [18F]AlF-OC uptake in the culprit and non-culprit carotid artery by measures of standardized uptake value (SUV)
Measured: 1 hour post-injection
Secondary outcomes (4)
Recurrence of ipsilaterial TIA, stroke or amaurosis fugax
Recurrence of ipsilateral TIA, amaurosis fugax and stroke during follow-up
Measured: 90 days, 1 year and 3 years after index event
Recurrence of all stroke/TIA
Recurrence of all stroke/TIA during follow-up
Measured: 90 days, 1 year and 3 years after the index event
Occurence of major adverse cardiovascular events (MACE)
Occurence of any vascular complication (stroke/TIA, myocardial infarction, cardiac arrest, hospitalisation for unstable angina or vascular death) during follow-up
Measured: 90 days, 1 year and 3 years after index event
Occurence of all-cause mortality
Occurence of all-cause mortality during follow-up
Measured: 90 days, 1 year, 3 years after index event
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start18 Mar 2025
- Primary completionSep 2026 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Stroke (CVA) or TIAStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robin Lemmens, MD PhD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07104487
- Sponsor's protocol ID
- S68914
- Other IDs
- 2024-515636-77
- Status last verified
- Oct 2024
- First submitted
- 29 Jul 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boeckxstaens L, Pauwels E, Vandecaveye V, Deckers W, Cleeren F, Dekervel J, Vandamme T, Serdons K, Koole M, Bormans G, Laenen A, Clement PM, Geboes K, Van Cutsem E, Nackaerts K, Stroobants S, Verslype C, Van Laere K, Deroose CM. Prospective comparison of [18F]AlF-NOTA-octreotide PET/MRI to [68Ga]Ga-DOTATATE PET/CT in neuroendocrine tumor patients. EJNMMI Res. 2023 Jun 1;13(1):53. doi: 10.1186/s13550-023-01003-3.
PubMed 37261615Pauwels E, Cleeren F, Tshibangu T, Koole M, Serdons K, Dekervel J, Van Cutsem E, Verslype C, Van Laere K, Bormans G, Deroose CM. [18F]AlF-NOTA-octreotide PET imaging: biodistribution, dosimetry and first comparison with [68Ga]Ga-DOTATATE in neuroendocrine tumour patients. Eur J Nucl Med Mol Imaging. 2020 Dec;47(13):3033-3046. doi: 10.1007/s00259-020-04918-4. Epub 2020 Jul 2.
PubMed 32617641Maes L, Versweyveld L, Evans NR, McCabe JJ, Kelly P, Van Laere K, Lemmens R. Novel Targets for Molecular Imaging of Inflammatory Processes of Carotid Atherosclerosis: A Systematic Review. Semin Nucl Med. 2024 Sep;54(5):658-673. doi: 10.1053/j.semnuclmed.2023.10.004. Epub 2023 Nov 23.
PubMed 37996309
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of [18F]AlF-NOTA-octreotide PET/MRI in Carotid Artery Disease
- ClinicalTrials.gov ID
- NCT07104487
- Acronym / sponsor ID
- S68914
- Conditions
- Stroke (CVA) or TIA, Carotid Artery Plaque, Atherosclerosis Cardiovascular Disease, Carotid Arteriosclerosis
- Keywords
- Internal Carotid Artery, Molecular Imaging, Atherosclerosis, Inflammation, PET/MRI, SST2, [18F]AlF-NOTA-octreotide, Stroke/TIA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 18 Mar 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 5 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Our study aims to assess the potential of molecular imaging with [18F]AlF-OC PET/MRI to characterize and quantify carotid atherosclerotic disease manifestations in patients with a recent stroke/TIA in the carotid artery territory. Eligible patients should have ≥30% stenosis in the ipsilateral carotid artery, as diagnosed by routine CTA. Additionally, we will evaluate the role of [18F]AlF-OC PET/MRI in risk stratification for recurrent events of patients with carotid artery stenosis and recent TIA/stroke.
This study is a single center study conducted at University Hospitals Leuven in Belgium. In a first part of this study, five patients will undergo serial [18F]AlF-OC PET/MRI at 60, 120 and 180 minutes after injection of 4 MBq/kg [18F]AlF-OC for protocol optimization and methodology refinement. In the second part of this trial, patients will undergo [18F]AlF-OC PET/MRI at the timepoint deemed as optimal based on the findings from the first part. All subjects will be required to undergo a screening and baseline assessment, an imaging visit ([18F]AlF-OC PET/MRI) and three follow-up visits (telephone interview at 90 days, 1 year and 3 years after the initial stroke onset). The primary outcome is the quantification of [18F]AlF-OC uptake in the carotid artery by measures of standardized uptake value (SUV). For every patient, both culprit (recent symptomatic event in ipsilateral carotid artery territory) and non-culprit (recent symptomatic event in the contralateral carotid artery territory) carotid arteries will be assessed. Secondary outcomes include the predictive value of baseline plaque SUV and TBR for the recurrence of ipsilateral TIA, amaurosis fugax and stroke during 3 years follow-up, the recurrence of all stroke/TIA, the occurrence of any vascular complication (stroke/TIA, myocardial infarction, cardiac arrest, hospitalisation for unstable angina or vascular death) and the occurrence of all-cause mortality.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: [18F]AlF-OC5 patients with ≥30% carotid artery stenosis on routine CT angiography (CTA) and a recent ischemic stroke in the supplying carotid artery territory will undergo [18F]AlF-OC PET/MRI at 60, 120 and 180 minutes after tracer injection. |
| Arm B | Experimental | Drug: [18F]AlF-OC19 patients with ≥30% carotid artery stenosis on routine CTA and a recent ischemic stroke/TIA in the supplying carotid artery territory will undergo [18F]AlF-OC PET/MRI at the timepoint deemed optimal in part A of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F]AlF-OCParticipants 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. | Drug | Arm B, Part A |
Primary outcome
Quantification of ICA [18F]AlF-OC uptake
Time frame: 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)
4 secondary outcomes
Recurrence of ipsilaterial TIA, stroke or amaurosis fugax
Time frame: 90 days, 1 year and 3 years after index event
Recurrence of all stroke/TIA
Time frame: 90 days, 1 year and 3 years after the index event
Occurence of major adverse cardiovascular events (MACE)
Time frame: 90 days, 1 year and 3 years after index event
Occurence of all-cause mortality
Time frame: 90 days, 1 year, 3 years after index event
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Background: PubMed 37261615Boeckxstaens L, Pauwels E, Vandecaveye V, Deckers W, Cleeren F, Dekervel J, Vandamme T, Serdons K, Koole M, Bormans G, Laenen A, Clement PM, Geboes K, Van Cutsem E, Nackaerts K, Stroobants S, Verslype C, Van Laere K, Deroose CM. Prospective comparison of [18F]AlF-NOTA-octreotide PET/MRI to [68Ga]Ga-DOTATATE PET/CT in neuroendocrine tumor patients. EJNMMI Res. 2023 Jun 1;13(1):53. doi: 10.1186/s13550-023-01003-3.
- Background: PubMed 32617641Pauwels E, Cleeren F, Tshibangu T, Koole M, Serdons K, Dekervel J, Van Cutsem E, Verslype C, Van Laere K, Bormans G, Deroose CM. [18F]AlF-NOTA-octreotide PET imaging: biodistribution, dosimetry and first comparison with [68Ga]Ga-DOTATATE in neuroendocrine tumour patients. Eur J Nucl Med Mol Imaging. 2020 Dec;47(13):3033-3046. doi: 10.1007/s00259-020-04918-4. Epub 2020 Jul 2.
- Background: PubMed 37996309Maes L, Versweyveld L, Evans NR, McCabe JJ, Kelly P, Van Laere K, Lemmens R. Novel Targets for Molecular Imaging of Inflammatory Processes of Carotid Atherosclerosis: A Systematic Review. Semin Nucl Med. 2024 Sep;54(5):658-673. doi: 10.1053/j.semnuclmed.2023.10.004. Epub 2023 Nov 23.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robin Lemmens, MD PhD principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing [18F]AlF-OC in people with Stroke (CVA) or TIA and Carotid Artery Plaque, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robin Lemmens, MD PhD (+32 16 34 42 80, robin.lemmens@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of ICA [18F]AlF-OC uptake (time frame: 1 hour post-injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07104487, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.