Radioactive tracer could spot hidden heart inflammation
NCT ID NCT07481136
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2031
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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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.