RecruitingNCT05838547

CANF-Comb-II PET-MR in Atherosclerosis Multisite

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

Sponsor

Washington University School of Medicine

Enrollment

80 participants

Start Date

Mar 21, 2023

Study Type

OBSERVATIONAL

Conditions

Carotid atherosclerosis Asymptomatic Carotid Artery Stenosis Carotid Artery Atheroma

Summary

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).

Eligibility

Min Age: 18 Years

Inclusion Criteria3

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 Criteria8

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 on the ipsilateral side.
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.

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Interventions

DRUG64Cu-25%-CANF-Comb

Patients treated with OMT alone that are not treated with CEA will receive an intravenous injection of 2-6 mCi of 64Cu-25%-CANF-Comb radiotracer for PET/MR imaging at the initial imaging visit and at 12-18 months, or earlier if they develop symptoms. While 12-18 months is the preferred window for repeat imaging, if imaging during this time frame is not achievable, the patient may return anytime throughout the remainder of the study.

DRUG64Cu-25%-CANF-Comb

Patients treated with OMT and CEA will receive an intravenous injection of 2-6 mCi of 64Cu-25%-CANF-Comb radiotracer for PET/MR imaging at the initial imaging visit.