NCT07104487

Brief 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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
40mo left

Started Mar 2025

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress26%
Mar 2025Sep 2029

Study Start

First participant enrolled

March 18, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 5, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2029

Last Updated

August 11, 2025

Status Verified

October 1, 2024

Enrollment Period

1.5 years

First QC Date

July 29, 2025

Last Update Submit

August 5, 2025

Conditions

Stroke (CVA) or TIACarotid Artery PlaqueAtherosclerosis Cardiovascular DiseaseCarotid Arteriosclerosis

Keywords

Internal Carotid ArteryMolecular ImagingAtherosclerosisInflammationPET/MRISST2[18F]AlF-NOTA-octreotideStroke/TIA

Outcome Measures

Primary Outcomes (1)

  • 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)

    1 hour post-injection

Secondary Outcomes (4)

  • Recurrence of ipsilaterial TIA, stroke or amaurosis fugax

    90 days, 1 year and 3 years after index event

  • Recurrence of all stroke/TIA

    90 days, 1 year and 3 years after the index event

  • Occurence of major adverse cardiovascular events (MACE)

    90 days, 1 year and 3 years after index event

  • Occurence of all-cause mortality

    90 days, 1 year, 3 years after index event

Study Arms (2)

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.

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.

Drug: [18F]AlF-OC

Interventions

[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.

Arm BPart A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify 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 stenosis. The stroke/TIA has occurred no more than 21 days prior to tracer administration.

You may not qualify 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, 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

Related Publications (3)

  • 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.

    PMID: 37261615BACKGROUND

  • Pauwels 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.

    PMID: 32617641BACKGROUND

  • Maes 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.

    PMID: 37996309BACKGROUND

MeSH Terms

Conditions

StrokeCarotid StenosisCarotid Artery DiseasesAtherosclerosisInflammation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesArterial Occlusive DiseasesArteriosclerosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Robin Lemmens, MD PhD

    UZ Leuven

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Robin Lemmens, MD PhD

CONTACT

+32 16 34 42 80robin.lemmens@uzleuven.be

Louise Maes, MD

CONTACT

+32 16 34 42 80louise.maes@uzleuven.be

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2025

First Posted

August 5, 2025

Study Start

March 18, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2029

Last Updated

August 11, 2025

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)