[18F]ALF-NOTA-OCTREOTIDE for Carotid artery atherosclerosis

Inclusion criteria

• {"criterion_text":"- Participant is aged over 18 years.\n- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedure\n- CT angiography imaging at baseline should be available as part of routine care\n- 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

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

Primary endpoints

• {"endpoint_text":"- The quantification of [18F]AlF-OC uptake in the culprit and non-culprit carotid artery by measures of standardized uptake value (SUV)","definition_or_measurement_approach":"Quantification performed by measures of standardized uptake value (SUV) of [18F]AlF-OC in culprit and non-culprit carotid arteries."}

Secondary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"Assessment of baseline plaque SUV predictive value for clinical events over 3 years of follow-up including ipsilateral TIA, amaurosis fugax, stroke, recurrence of all stroke/TIA, vascular complications (stroke/TIA, MI, cardiac arrest, hospitalisation for unstable angina, vascular death) and all-cause mortality."}

Belgium

Earliest CTIS Part Ii Submission Date

25-10-2024

Latest Decision Or Authorization Date

18-03-2026

Processing Time Days

509

Number Of Sites

1

Number Of Participants

24

Primary sponsor

Full Name

UZ Leuven

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Belgium