MCE Molecular Imaging for ICI Myocarditis

University of Virginia

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Immune Checkpoint Inhibitor Myocarditis

Treatments: Diagnostic Test: Myocardial contrast echocardiography molecular imaging for inflammation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07538544

HSR 303588

Details and patient eligibility

About

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).

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Patients with suspected ICI Myocarditis

Experimental group

Description:

Patients with any degree of suspicion for ICI myocarditis based on symptoms, lab tests, ECG, or imaging tests.

Treatment:

Diagnostic Test: Myocardial contrast echocardiography molecular imaging for inflammation