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NCT Number: NCT07538544

MCE Molecular Imaging for ICI Myocarditis

Inflammation of the heart (myocarditis) is a serious condition that can cause heart failure, abnormal heart rhythms, cardiac arrest, and death. A new class of medications used for cancer called immune checkpoint inhibitors (ICI) work by increasing the body's inflammmation response, but can have a side effect of causing inflammation of the heart (ICI myocarditis). Rapid diagnosis of this condition is key to reversing it. The purpose of this study is to determine whether ICI myocarditis can be diagnosed using a new form of ultrasound imaging of the heart (echocardiography) that uses a contrast agent that is targeted to inflammation (Sonazoid).

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Key information

Conditions

Immune Checkpoint Inhibitor Myocarditis Cardiomyopathies Cardiovascular Diseases Heart Diseases Myocarditis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location contact

Jonathan Lindner, MD

CONTACT

[email protected]

14342979442

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years of age
  • Treatment with single or combination ICI therapy targeted to CTLA-4, PD-1, or PD-L1 with an ICI within the past week
  • At least two of the following manifestations of ICI myocarditis:
  • new or suspected new high-sensitivity troponin >3 times upper limit of normal
  • new or suspected new LV dysfunction with LVEF <50% or any segmental wall motion abnormality in the absence of prior ischemic event
  • ECG changes consistent with myocarditis defined as either diffuse ST elevation or ST-T abnormalities that are documented to be new,
  • unexplained severe ventricular arrhythmias,
  • Cardiac MR evidence for myocarditis

Exclusion criteria

  • 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.)

Treatment and study plan

Myocardial contrast echocardiography molecular imaging for inflammation

Diagnostic Test

Myocardial contrast echocardiography (ultrasound of the heart) using an ultrasound contrast agent (Sonazoid, GE Healthcare) that contains phosphatidylserine, thereby targeting it to leukocytes and activated endothelium.

Primary outcomes

  1. Diagnostic accuracy for presence/absence of ICI Myocarditis

    Time frame: 3 months

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

Secondary outcomes

  1. Response to therapy

    Time frame: 3 month

    The ability of MCE molecular imaging to detect a reduction in inflammation as a response to immune suppressive therapy will be evaluated by repeat MCE molecular imaging 14 days after starting immune suppressive therapy, and evaluation of cardiac function at 3 months.

Study contacts

Contact information is provided by the study sponsor or research team.

Jonathan Lindner, MD

CONTACT

[email protected]

14342979442

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

  • GE Healthcare

Registry information

Official study title

MCE Molecular Imaging in ICI Myocarditis

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Apr 20, 2026
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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