MedTrace Logo

CANF-Comb-II PET-MR in Atherosclerosis Multisite

NCT05838547 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2026-03-23

No results posted yet for this study

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).

Conditions

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

Interventions

DRUG

64Cu-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.

DRUG

64Cu-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.

Sponsors & Collaborators

  • Cedars-Sinai Medical Center

    collaborator OTHER

  • University of California, Santa Barbara

    collaborator OTHER

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Pamela Woodard, MD · Washington University School of Medicine

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-21
Primary Completion
2027-05-31
Completion
2027-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05838547 on ClinicalTrials.gov