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New scan could spot hidden stroke risk in blocked arteries

NCT ID NCT05838547

Knowledge-focused Sponsor: Washington University School of Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing whether a new type of PET-MR scan can help predict stroke risk in people with significant narrowing of the carotid artery (the main artery in the neck) who have not yet had symptoms. Researchers will give participants an injection of a radioactive tracer and take images of their arteries. They will then follow participants for up to 18 months to see who has a stroke or needs treatment, to see if the scan signal correlates with risk.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
64Cu-25%-CANF-Comb (a radioactive tracer for PET imaging)
What this could lead to
If successful, this could lead to a better way to identify which patients with carotid artery narrowing are at highest risk for stroke, helping guide treatment decisions.
What could go wrong
This is an early observational study, not a treatment trial. The imaging technique may not prove accurate enough to predict risk, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2023

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Individuals ≥18 years of age with asymptomatic carotid artery stenosis.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder carotid artery disorder carotid stenosis stroke disorder vascular disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Asymptomatic carotid artery stenosis Carotid artery atheroma Carotid atherosclerosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cedars Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

  • Washington University in St. Louis

    RECRUITING

    St Louis, Missouri, 63130-2344, United States

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