MCE Molecular Imaging for ICI Myocarditis
Starting soon · Early Phase 1
Conditions studied: Immune Checkpoint Inhibitor Myocarditis
In brief
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).
Key facts
- Study ID
- NCT07538544
- Run by
- University of Virginia
- People needed
- 30
- Starts
- 2026-07-01
- Expected to finish
- 2030-07-01
- Last updated by the study team
- 2026-04-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.)
Where it is running
- University of Virginia — Charlottesville, Virginia, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.