CANF-Comb-II PET-MR in Atherosclerosis Multisite

Conditions

• Asymptomatic Carotid Artery Stenosis
• Carotid Artery Atheroma
• Carotid Atherosclerosis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 64Cu-25%-CANF-Comb — DRUG
  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.
• 64Cu-25%-CANF-Comb — DRUG
  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.

Study Details

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).

Key Dates

Start date

Mar 21, 2023

Status verified

Mar 2026

Primary completion

May 31, 2027

Completion

May 31, 2027

Study Design

Enrollment

80 participants (estimated)

Arms

• Arm: Patients treated with Optimal Medical Therapy (OMT) alone.
  Asymptomatic carotid artery stenosis (ACAS) patients with known carotid artery atherosclerosis by ultrasound/Doppler or other carotid imaging ≥ 60% diameter stenosis who are clinically referred for OMT alone.
• Arm: Patients treated with OMT and carotid endarterectomy (CEA).
  Asymptomatic carotid artery stenosis (ACAS) patients with known carotid artery atherosclerosis by ultrasound/Doppler or other carotid imaging ≥ 60% diameter stenosis who are clinically referred for OMT and CEA.

Primary Outcome Measure

Number of patients reporting ipsilateral ischemic cerebrovascular event (TIA, stroke) or remote ipsilateral carotid intervention [ Time Frame: Through study completion, up to 4 years. ]

Central Contacts

• Molly Mohrman
  314-747-4633
  [email protected]
• Pamela Woodard, MD
  314-362-7100
  [email protected]

Locations (2)

Find similar trials in Los Angeles, CA

Related Studies

• PET Detection of CCR2 in Human Atherosclerosis
  PHASE1 · Recruiting · Washington University School of Medicine · St Louis, Missouri