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

Our study aims to assess the potential of molecular imaging with \[18F\]AlF-OC PET/MRI to characterize and quantify carotid atherosclerotic disease manifestations in patients with a recent stroke/TIA in the carotid artery territory. Eligible patients should have ≥30% stenosis in the ipsilateral carotid artery, as diagnosed by routine CTA. Additionally, we will evaluate the role of \[18F\]AlF-OC PET/MRI in risk stratification for recurrent events of patients with carotid artery stenosis and recent TIA/stroke. This study is a single center study conducted at University Hospitals Leuven in Belgium. In a first part of this study, five patients will undergo serial \[18F\]AlF-OC PET/MRI at 60, 120 and 180 minutes after injection of 4 MBq/kg \[18F\]AlF-OC for protocol optimization and methodology refinement. In the second part of this trial, patients will undergo \[18F\]AlF-OC PET/MRI at the timepoint deemed as optimal based on the findings from the first part. All subjects will be required to undergo a screening and baseline assessment, an imaging visit (\[18F\]AlF-OC PET/MRI) and three follow-up visits (telephone interview at 90 days, 1 year and 3 years after the initial stroke onset). The primary outcome is the quantification of \[18F\]AlF-OC uptake in the carotid artery by measures of standardized uptake value (SUV). For every patient, both culprit (recent symptomatic event in ipsilateral carotid artery territory) and non-culprit (recent symptomatic event in the contralateral carotid artery territory) carotid arteries will be assessed. Secondary outcomes include the predictive value of baseline plaque SUV and TBR 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.