An exploratory study of [18F]AlF-NOTA-octreotide high resolution NeuroEXPLORER PET and MRI in carotid artery disease

Overview

Sponsor-declared trial summary

Key facts

Sponsor

UZ Leuven

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

16 Mar 2025 → ongoing

Decision date (initial)

2024-11-18

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

This single-center prospective study aims to evaluate the potential of [18F]AlF-OC high resolution NeuroEXPLORER PET and MRI in characterizing and quantifying carotid atherosclerotic disease in patients with recent stroke/TIA.

Secondary objectives 1

1. To determine a role for [18F]AlF-OC PET/MRI in identifying the risk for ipsilateral recurrent stroke in patients with recent carotid territory ischemia and ≥30% carotid artery stenosis.

Conditions and MedDRA coding

Carotid artery atherosclerosis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Participant is aged over 18 years.
2. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedure
3. CT angiography imaging at baseline should be available as part of routine care
4. Participant is diagnosed with a recent ischemic stroke or high-risk TIA (ABCD2 ≥ 4) in the carotid artery territory and an atherosclerotic plaque of ≥ 3 mm thickness in the ipsilateral internal carotid artery.. The stroke/TIA has occurred no more than 21 days prior to tracer administration.

Exclusion criteria 8

1. Female who is pregnant or breast-feeding.
2. Participants with a cardio-embolic stroke, small vessel stroke or other defined stroke etiology according to the TOAST classification
3. 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
4. Participants treated with carotid endarterectomy or carotid artery stenting within the past year
5. Subject has a contra-indication for or cannot tolerate MR scanning
6. 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)
7. Concurrent treatment with corticosteroids and/or somatostatin analogues
8. Subject is unwilling or unable to perform all of the study procedures, or is considered unsuitable in any way by the principal investigator

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The quantification of [18F]AlF-OC uptake in the culprit and non-culprit carotid artery by measures of standardized uptake value (SUV)

Secondary endpoints 1

1. The predictive value of baseline plaque SUV 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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

UZ Leuven

Sponsor organisation

UZ Leuven

Address

Herestraat 49

City

Leuven

Postcode

3000

Country

Belgium

Scientific contact point

Organisation

UZ Leuven

Contact name

Lemmens Robin

Public contact point

Organisation

UZ Leuven

Contact name

Lemmens Robin

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications