Washington University School of Medicine
The goal of this clinical trial is to evaluate the feasibility of imaging atherosclerosis by 64Cu-NODAGA-CANF PET-MR in a pilot study of patients with asymptomatic carotid artery stenosis (ACAS). The main question it aims to answer is: Can 64Cu-NODAGA-CANF PET detect carotid atherosclerosis in patients with ACAS? Uptake of 64Cu-NODAGA-CANF as measured by PET-MR will also be correlated to anatomic features of plaque on MRI, outcomes for patients treated with optimal medical therapy (OMT) alone or OMT and carotid endarterectomy (CEA) surgery, and tissue measurements for patients undergoing CEA surgery. The ability of 64Cu-NODAGA-CANF to risk stratify ACAS patients treated with OMT alone with respect to patient outcomes will be determined. Participants will * Receive a single intravenous (IV) administration of 64Cu-NODAGA-CANF followed by dynamic PET-MR imaging for up to 60 minutes and a second optional scan between 1-4 hours post-injection. * Undergo physical examinations, vital sign measurements, and blood and urine collection for clinical laboratory tests. * Undergo standard of care treatment with either OMT alone or OMT and CEA surgery. * Be evaluated with phone interviews 48-72 hours (2-3 days) after discharge and every 3 months (+/- 5 days) to assess for ipsilateral ischemic cerebrovascular event (transient ischemic attack (TIA), stroke) or remote ipsilateral carotid intervention.
This study is a Phase 1, multicenter, open-label baseline controlled imaging study designed to assess whether 64Cu-NODAGA-CANF PET-MR can detect carotid atherosclerosis in patients with ACAS. A total of 30 subjects, both men and women (≥18 years of age), will be recruited at Washington University and Cedars Sinai, with approximately 25 patients recruited at Washington University and approximately 5 patients recruited at Cedars Sinai. Patients will receive a single intravenous (IV) bolus injection of 8-10 mCi of the investigational radiotracer 64Cu-NODAGA-CANF followed by dynamic PET-MR imaging…
Inclusion Criteria: * Adults, 18 years of age or older. * Asymptomatic carotid artery stenosis patients who have undergone carotid Doppler/ultrasound imaging or other carotid imaging which have demonstrated a ≥ 60% diameter carotid artery stenosis. * The treating surgeon has planned either treatment with optimal medical therapy (OMT) alone or OMT and carotid endarterectomy (CEA) surgical intervention. Exclusion Criteria: * Inability to receive and sign informed consent. * Patients with an unstable clinical condition that in the opinion of the Sponsor-Investigator or designee precludes parti…
Patients will receive a single intravenous (IV) injection of 8-10 mCi of 64Cu-NODAGA-CANF for PET-MR imaging at the imaging visit.