MCE Molecular Imaging for ICI Myocarditis Phase 1 Trial
Summary
NIH registered a Phase 1 clinical trial (NCT07538544) evaluating whether myocardial contrast echocardiography using Sonazoid, an inflammation-targeted contrast agent, can diagnose immune checkpoint inhibitor (ICI) myocarditis. The single-arm study will assess this diagnostic approach in patients receiving ICI cancer therapy who develop suspected myocarditis. This study addresses a critical diagnostic gap, as rapid identification of ICI myocarditis is essential for reversing this potentially fatal adverse event.
“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).”
What changed
NIH added a Phase 1 clinical trial registry entry for a study evaluating myocardial contrast echocardiography molecular imaging with Sonazoid contrast agent as a diagnostic tool for ICI myocarditis. The trial will determine if targeted ultrasound imaging can rapidly identify heart inflammation caused by immune checkpoint inhibitor cancer drugs.
Healthcare providers administering immune checkpoint inhibitors should be aware that a diagnostic imaging study is underway that could establish new protocols for identifying ICI-related myocarditis. Clinical investigators conducting ICI-related research may find this registry entry relevant for understanding emerging diagnostic approaches to this serious adverse event.
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Apr 21, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
MCE Molecular Imaging for ICI Myocarditis
Early Phase 1 NCT07538544 Kind: EARLY_PHASE1 Apr 20, 2026
Abstract
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).
Conditions: Immune Checkpoint Inhibitor Myocarditis
Interventions: Myocardial contrast echocardiography molecular imaging for inflammation
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