Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07104487

[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

232 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

[18F]AlF-NOTA-octreotide PET/MRI in Carotid Artery Disease

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participant is aged over 18 years.
  • Voluntary written informed consent has been obtained before screening.
  • CT angiography imaging at baseline is available as part of routine care.
  • Participant has a recent ischemic stroke or high-risk TIA (ABCD2 64) in the carotid artery area with 64 30% carotid artery stenosis.
  • Stroke or TIA occurred no more than 21 days before tracer injection.
Not Eligible

You will not qualify if you...

  • Female who is pregnant or breastfeeding.
  • Participants with cardio-embolic stroke, small vessel stroke, or other stroke types per TOAST classification.
  • Presence of chronic or recurrent disease that may interfere with the study.
  • Participants treated with carotid endarterectomy or carotid artery stenting within the past year.
  • Contraindication to or inability to tolerate MRI.
  • Impaired kidney function with eGFR less than 40 ml/min/1.73m8.
  • Concurrent treatment with corticosteroids or somatostatin analogues.
  • Unwillingness or inability 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

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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

CONTACT

L

Louise Maes, MD

CONTACT

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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