64Cu-GRIP B for Myocarditis

JJ
Overseen ByJavid J Moslehi, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new imaging tool called 64Cu-GRIP B PET to better diagnose acute myocarditis, an inflammation of the heart muscle. The tool highlights areas of heart inflammation and damage by detecting certain immune cells in action. Patients diagnosed with acute myocarditis who show signs of heart damage, such as abnormal heart tests, might be suitable candidates. The goal is to improve the accuracy of diagnosing this condition and potentially aid in monitoring treatments in the future. As a Phase 1 trial, the research focuses on understanding how this new imaging tool functions in people, offering participants the opportunity to be among the first to benefit from this innovative diagnostic approach.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are on systemic anticancer therapies, radiation, or antibody therapy, you must have stopped them for a certain period before joining the trial.

What prior data suggests that 64Cu-GRIP B is safe for myocarditis patients?

Research is examining the safety of 64Cu-GRIP B, a special substance used in PET scans. Currently, detailed information about its safety in humans is limited because it remains in the early testing stages. While doctors remain hopeful, they continue to learn about human reactions and potential side effects.

In similar studies, substances like 64Cu-GRIP B highlight specific cells or activities in the body. Although these substances have undergone safety testing before, each new one requires its own safety evaluation. Since this study is in the early phase, the primary goal is to ensure the substance does not cause harmful side effects.

Researchers closely monitor participants in early trials like this one to observe bodily responses. If past studies with similar substances serve as a guide, 64Cu-GRIP B might be well-tolerated, but researchers need more data to confirm this.12345

Why are researchers excited about this trial?

Unlike the standard treatments for myocarditis, which often include anti-inflammatory medications and immune system suppressants, 64Cu-GRIP B is unique because it uses a radiotracer for PET imaging to potentially identify inflammation directly. This approach allows doctors to visualize and track the condition in real-time, offering a more precise and personalized assessment of the disease. Researchers are excited about 64Cu-GRIP B because it could lead to earlier detection and tailored treatments, potentially improving outcomes for patients with acute myocarditis.

What evidence suggests that 64Cu-GRIP B is effective for detecting acute myocarditis?

Research has shown that 64Cu-GRIP B is a promising tool for detecting myocarditis, which is inflammation of the heart. This tracer targets a protein called granzyme B, released by immune cells that attack heart cells. By highlighting where these immune cells are active, 64Cu-GRIP B may help identify heart inflammation more precisely. Early studies suggest it could improve the accuracy of diagnosing myocarditis. In this trial, participants with acute myocarditis will receive 64Cu-GRIP B to evaluate its effectiveness in detecting heart inflammation. Although this is the first study of its kind in humans, the method shows potential for spotting inflammation related to heart damage.12678

Are You a Good Fit for This Trial?

This trial is for adults (18+) with confirmed acute myocarditis, who have healthy major organs and can follow study instructions. People with certain other heart conditions, recent heart attacks or infections, pregnant/breastfeeding women, or those allergic to PET tracers cannot join.

Inclusion Criteria

My bone marrow, liver, and kidneys are working well.
Ability to understand and the willingness to sign a written informed consent document
I am 18 years old or older.
See 6 more

Exclusion Criteria

I do not have recent serious heart problems or a recent viral infection.
Pregnant women and breastfeeding women treated with 64Cu-GRIP B are excluded
I have recently received cancer treatments like chemotherapy, radiation, or antibody therapy.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 64Cu-GRIP B intravenously and undergo whole body PET imaging 4 hours post-injection

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including association between PET uptake and immune parameters

10 weeks
Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • 64Cu-GRIP B

Trial Overview

The study tests a new imaging tracer called 64Cu-GRIP B in patients with acute myocarditis. This tracer helps detect inflammation in the heart by highlighting immune cell activity using a special PET scan. The goal is to see how well it identifies areas of heart damage.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Cohort A: participants with acute myocarditis (5 males, 5 females)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Javid Moslehi, MD

Lead Sponsor

Citations

64Cu-GRIP B in Patients With Acute Myocarditis

The proposed patient study represents the first-ever acute myocarditis patient imaging study with 64Cu-GRIP B PET. The tracer is designed to detect ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41381234/

Preclinical Evaluation of 64Cu-LNTH-1363S to Detect ...

The aim of this study was to evaluate a new PET tracer, 64Cu-LNTH-1363S, to detect FAP+ fibroblasts in myocardial infarction (MI) mouse models.

64Cu-GRIP B for Myocarditis · Info for Participants

The study population is focused on patients with acute myocarditis to assess the specificity and sensitivity of 64Cu-GRIP B to detect myocarditis. In future ...

64Cu-GRIP B in Patients With Advanced Malignancies

This phase I/II clinical trial evaluates if using a radiotracer targeting granzyme B, 64-copper granzyme targeting restricted interaction peptide specific ...

PET Imaging Study of 64Cu-GRIP B for Patients Receiving ...

This is a phase I/Ib imaging study of granzyme B, 64-copper granzyme targeting restricted interaction peptide specific to family member B (64Cu-GRIP B) ...

Radiotracer (64Cu-GRIP B) Targeting Granzyme B with ...

This phase I/II clinical trial evaluates if using a radiotracer called 64 Cu-GRIP B with positron emission tomography (PET) imaging can be safe and useful ...

PET Imaging Study of 64Cu-GRIP B for Patients Receiving ...

To assess the safety of 64Cu-GRIP B in participants with NHL undergoing CAR-T cell therapy. Participants will be initially enrolled in Cohort 1. Based on the ...

8.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41370400/

Inhibition of CXCL10 and IFN-γ ameliorates myocarditis in ...

Neutralization of CXCL10 and IFN-γ during the second dose (21 days after the first dose) reduced vaccine-induced cardiac injury in mice.