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MCE Molecular Imaging for ICI Myocarditis

This study is looking into a new way to diagnose a serious heart condition called immune checkpoint inhibitor (ICI) myocarditis. This condition can happen as a side effect of certain cancer medications (immune checkpoint inhibitors) that boost your body's immune response. Researchers are testing if a special type of heart ultrasound (echocardiography) using a contrast agent called Sonazoid can accurately find this heart inflammation. Sonazoid helps highlight areas of inflammation. The main goal is to see how accurate this imaging method is at detecting ICI myocarditis after 3 months. You may be able to join if you are 18 or older, have recently received ICI therapy, and show at least two signs of ICI myocarditis, such as elevated troponin levels. The current status of this study is unclear, and it plans to enroll 30 participants.

Study design
This is an interventional study, meaning participants will receive a specific diagnostic test. It aims to enroll 30 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for diagnostic accuracy is measured at 3 months.

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NCT07538544

MCE Molecular Imaging for Myocarditis

Not Yet Recruiting
EARLY_PHASE1Ages 18+InterventionalDiagnostic
University of Virginia
~30 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:Myocardial contrast echocardiography molecular imaging for inflammation

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Diagnostic accuracy for presence/absence of Myocarditis
Measured over 3 months

Conditions

Myocarditis Acute

Explore related trials

Myocarditis

Where it's being run

1 sites across 1 states
Virginia1

Study leadership

  • Jonathan Lindner · PRINCIPAL_INVESTIGATOR · University of Virginia

Who to contact

Jonathan Lindner, MD
[email protected]
14342979442
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age ≥18 years of age
At least two of the following manifestations of myocarditis:

Exclusion

Inability to obtain consent
High pre-test likelihood for ACS based on ECG and history
Pregnancy or planned pregnancy
Lactation
Allergy to ultrasound contrast agents or eggs
Treatment with potent immunosuppressive therapy beyond corticosteroids
Conditions associated with inflammatory myopathy (SLE, giant cell myocarditis, sarcoidosis, etc.)

What this trial measures

  • Diagnostic accuracy for presence/absence of Myocarditis3 months

    The ability of of MCE molecular imaging with Sonazoid to diagnose myocarditis will be determined by comparing to a gold standard (either cardiac MRI or myocardial biopsy).