Imaging plaque biology in patients with asymptomatic carotid artery stenosis
PET-MR Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis With Cu[64]-25%-CANF-Comb-II
This study is testing a new imaging method to see how plaque in the carotid arteries affects the risk of strokes in people who have narrowing of these arteries but don’t have any symptoms.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 2 sites (Los Angeles, California and 1 other locations) |
| Trial ID | NCT05838547 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate plaque biology in patients with asymptomatic carotid artery stenosis (ACAS) using advanced imaging techniques. Participants will undergo a carotid PET-MRI examination after receiving an intravenous injection of a radiotracer, 64Cu-CANF-Comb, to assess its uptake and correlate it with patient outcomes such as stroke or transient ischemic attack. The study will include 80 subjects and is designed to enhance understanding of the role of Natriuretic Peptide Receptor C in carotid atherosclerosis progression. The findings could help in risk stratification for stroke events in ACAS patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with asymptomatic carotid artery stenosis of 60% or greater as confirmed by imaging.
Not a fit: Patients with a recent history of stroke or TIA, or those unable to comply with study procedures, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved risk assessment and management strategies for patients with asymptomatic carotid artery stenosis.
How similar studies have performed: Previous studies have shown promising results with similar imaging approaches, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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.
Where this trial is running
Los Angeles, California and 1 other locations
- Cedars Sinai Medical Center — Los Angeles, California, United States (Recruiting)
- Washington University in St. Louis — St Louis, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Pamela Woodard, MD — Washington University School of Medicine
- Study coordinator: Molly Mohrman
- Email: mohrmanm@wustl.edu
- Phone: 314-747-4633
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.