An Exploratory Study of [18F]AlF-NOTA-octreotide PET/MRI in Carotid Artery Disease

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Belgium
UZ Leuven
RECRUITING
Leuven
Contact Information
Primary
Robin Lemmens, MD PhD
robin.lemmens@uzleuven.be
+32 16 34 42 80
Backup
Louise Maes, MD
louise.maes@uzleuven.be
+32 16 34 42 80
Time Frame
Start Date: 2025-03-18
Estimated Completion Date: 2029-09
Participants
Target number of participants: 24
Treatments
Experimental: Part A
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.
Experimental: Arm B
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.
Sponsors
Leads: Universitaire Ziekenhuizen KU Leuven

This content was sourced from clinicaltrials.gov