Can a new tracer reveal hidden plaque in arteries?

NCT ID NCT07800481

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This trial tests an experimental imaging tracer called 64Cu-NODAGA-CANF in healthy adults. The goal is to measure how the tracer spreads through the body, calculate the radiation dose, and check its safety. Each participant receives one injection of the tracer and then undergoes PET-CT scans at several time points over two days. The results will help determine if this tracer can be used in future studies to image plaque buildup in arteries.

What this could mean

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

Active substance
64Cu-NODAGA-CANF, an experimental PET imaging tracer
What this could lead to
If successful, this could lead to a safer, more precise imaging method to detect and monitor plaque in arteries, potentially improving prevention of heart attacks and strokes.
What could go wrong
This is an early-phase trial with only 8 healthy volunteers, so results may not apply to patients with disease. The tracer is experimental, and its safety and effectiveness are not yet proven.

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.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 8 people

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

Started

Aug 2026

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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. * Healthy adult normal volunteer subjects (4 males and 4 females). "Healthy adult normal volunteer subject" is someone who has volunteered to be imaged and who, based on physical exam and baseline electrocardiogram, has no evidence of cardiovascular disease and is not under the care of a physician for any active medical conditions. 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 above head for PET-CT. * Normal adult volunteer subjects with evidence of disease based on clinical evaluation and/or blood laboratory tests, which are judged by the Sponsor-Investigator or designee to interfere with the objectives of the protocol. * Prior history of carotid endarterectomy (CEA) or carotid artery stent procedure on the ipsilateral side. * Past medical history of transient ischemic attack (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. * Claustrophobia or other preventing condition that has previously or would interfere with completion of imaging as outlined in the protocol. * Participation in another research study with an investigational drug, including a diagnostic or therapeutic radiopharmaceutical, currently or within the last year. * 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-NODAGA-CANF 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.

As listed by the trial registrant

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

How to take part

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  1. The places running it

    1 site. 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

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

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