PET-MR Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis With Cu[64]-25%-CANF-Comb-II

202210116

The goal of this observational study is to learn more about plaque biology in asymptomatic carotid artery stenosis (ACAS) patients through imaging. The main questions it aims to answer are: * To determine the ability of 64Cu-CANF-Comb positron emission tomography (PET) to risk stratify ACAS patients for stroke event, to include transient ischemic attack or remote ipsilateral intervention. * To further understand the role of Natriuretic Peptide Receptor C (NPRC) in the evolution of carotid atherosclerosis. Participants will be asked to undergo a carotid PET-magnetic resonance imaging (MRI) examination to assess whether the carotid atherosclerosis uptake of 64Cu-CANF-Comb as measured by PET-MRI correlates with patient outcomes (stroke, transient ischemic attack, or remote ipsilateral intervention).

2023-03-21

2027-05-31

2027-05-31

Recruiting

80

Inclusion Criteria: * Adults, 18 years of age or older * Patients who have undergone carotid Doppler/ultrasound 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 participation in the study. * Inability to tolerate up to 60 minutes in a supine position with arms down at sides for PET-MR imaging. * Prior history of CEA or carotid artery stent procedure. * Past medical history of TIA or stroke within the last 6 months. * Unwilling to comply with study procedures and/or unable to be available for the duration of the study outlined in the protocol. * Contraindications to MR imaging (pacemaker, brain aneurysm clips, shrapnel, claustrophobia, etc.). * Currently pregnant or lactating. All female subjects of childbearing potential must have a documented negative pregnancy test (serum or urine hCG) performed within 24 hours immediately prior to the administration of 64Cu-25%-CANF-Comb or documented post- menopausal defined as the cessation of menses for ≥ 12 months or documentation of having a bilateral oophorectomy and/or hysterectomy.

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Carotid plaque tissue specimens will be collected at the time of surgery.'}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}

2024-05-06