Not Yet RecruitingEarly Phase 1

MCE Molecular Imaging for ICI Myocarditis

United States30 participantsStarted 2026-07-01

Plain-language summary

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).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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

What they're measuring

Diagnostic accuracy for presence/absence of ICI Myocarditis

Timeframe: 3 months

Trial details

NCT IDNCT07538544

SponsorUniversity of Virginia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-06-30

Contact for this trial

Jonathan Lindner, MD

14342979442 jlindner@virginia.edu

View on ClinicalTrials.gov More Immune Checkpoint Inhibitor Myocarditis trials