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Radioactive tracer could spot hidden heart inflammation

NCT ID NCT07481136

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This early study tests a new radioactive tracer called 64Cu-GRIP B that targets a protein released by immune cells during heart inflammation. Researchers will scan 10 people with acute myocarditis to see if the tracer can clearly highlight inflamed areas of the heart. If it works, this method could improve diagnosis and help doctors monitor treatment without invasive biopsies.

What this could mean

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

Active substance
64Cu-GRIP B (a radioactive tracer for PET scans)
What this could lead to
If successful, this could lead to a more accurate and non-invasive way to diagnose acute myocarditis and monitor treatment response.
What could go wrong
This is a very early phase 1 study with only 10 participants, so results may not apply broadly. The tracer may not reliably detect inflammation in all cases.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 10 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Jan 2031

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 to 85 years

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: 1. Participants must have histologically or cytologically confirmed myocarditis in accordance with the Dallas Criteria 2. The subject is able and willing to comply with study procedures and provide signed and dated informed consent 3. Age ≥18 years 4. Demonstrates adequate organ function as defined below: Adequate bone marrow function: absolute neutrophil count ≥1,500/mcL platelets ≥100,000/mcL Adequate hepatic function: total bilirubin within normal institutional limits, unless elevated due to Gilbert's syndrome and direct bilirubin is within normal limits AST(SGOT) ≤3 X institutional upper limit of normal ALT(SGPT) ≤3 X institutional upper limit of normal Adequate renal function: creatinine ≤ 1.5 x within institutional upper limit of normal OR creatinine clearance GFR ≥ 60 mL/min/1.73 m2, calculated using the Cockcroft-Gault equation, unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m2 5. Ability to understand and the willingness to sign a written informed consent document. 6. Human immunodeficiency virus (HIV)-infected individuals on effective antiretroviral therapy with undetectable viral load within 6 months are eligible for this trial. 7. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. 8. Individuals with a history of hepatitis C virus (HCV) infection must have been treated and cured. For individuals with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. 9. The effects of 64Cu-GRIP B on the developing human fetus are unknown. For this reason and because a diagnostic PET radiotracer that is used in this trial is known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception for the duration of study participation and for 2 weeks after last administration of study drug. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 2 weeks after administration of study drug. Exclusion Criteria: 1. Has received systemic anticancer therapies within 3 weeks of first dose, radiation within 2 weeks, antibody therapy within 4 weeks. Concomitant administration of LHRH analogues for prostate cancer and somatostatin analogues for neuroendocrine tumors are allowed as per standard of care. 2. Has not recovered from adverse events due to prior anti-cancer therapy to ≤ grade 1 or baseline (other than alopecia). 3. Is currently receiving any other investigational agents. 4. Has participated in a study of an investigational product and received study treatment or used an investigational device within 6 weeks of the first dose of study drug. 5. Any other cardiac condition that may result in non-specific findings, including recent (within 6 months) Acute Coronary Syndrome or Type II NSTEMI. Participants with a recent viral infection, such as Influenza A, will also be excluded. 6. Hypersensitivity to PET radiotracers or any of its excipients. 7. Pregnant women are excluded from this study because 64Cu-GRIP B is a PET radiotracer with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to assessment of the mother with 64Cu-GRIP B, breastfeeding should be discontinued if the mother is treated with 64Cu-GRIP

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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

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

  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

  • University of California, San Francisco

    San Francisco, California, 94143, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.