Recruiting

CANF-Comb-II

Sponsor:

Washington University School of Medicine

Code:

NCT05838547

Conditions

Carotid Atherosclerosis

Asymptomatic Carotid Artery Stenosis

Carotid Artery Atheroma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

64Cu-25%-CANF-Comb

64Cu-25%-CANF-Comb

Study Details

Brief 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

Study ID

NCT05838547

Start date

Mar 21, 2023

Status verified date

Mar, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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.

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 and Locations

Central contacts

Molly Mohrman

314-747-4633mohrmanm@wustl.edu

Pamela Woodard, MD

314-362-7100woodardp@wustl.edu

Locations

Cedars Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Yibin Xie, Ph.D

Yibin.Xie@cshs.org

Washington University in St. Louis

Recruiting

St Louis, Missouri, United States, 63130-2344

Contacts

Pamela K Woodard, MD

woodardp@wustl.edu

More Information

Sponsor

Washington University School of Medicine

Last update posted

Mar 23, 2026

Last verified

Mar, 2026

Keywords

  • Stroke
  • TIA
  • Vascular Disease
  • Cardiovascular Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-03-23.