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Not yet recruiting Early Phase 1 NCT07538544

MCE Molecular Imaging for ICI Myocarditis

Very early trial – mainly for safety
Conditions: Immune Checkpoint Inhibitor Myocarditis

Sponsor: University of Virginia

trial.available_in: БГ
Overview
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
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: 1. new or suspected new high-sensitivity troponin \>3 times upper limit of normal 2. new or suspected new LV dysfunction with LVEF \<50% or any segmental wall motion abnormality in the absence of prior ischemic event 3. ECG changes consistent with myocarditis defined as either diffuse ST elevation or ST-T abnormalities that are documented to be new, 4. unexplained severe ventricular arrhythmias, 5. 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.)
Interventions
Myocardial contrast echocardiography molecular imaging for inflammation
DIAGNOSTIC_TEST
Locations 1
United States (1)
University of Virginia
Charlottesville , Virginia
Technical details
Status
Not yet recruiting
Phase
Early Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
01.07.2026
Completion date
01.07.2030
Registry ID
NCT07538544
Source
clinicaltrials.gov
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