MCE Molecular Imaging for ICI Myocarditis

Conditions

• Immune Checkpoint Inhibitor Myocarditis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Myocardial contrast echocardiography molecular imaging for inflammation — DIAGNOSTIC_TEST
  Myocardial contrast echocardiography (ultrasound of the heart) using an ultrasound contrast agent (Sonazoid, GE Healthcare) that contains phosphatidylserine, thereby targeting it to leukocytes and activated endothelium.

Study Details

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 Dates

Start date

Jul 1, 2026

Status verified

Apr 2026

Primary completion

Jun 30, 2030

Completion

Jul 1, 2030

Study Design

Enrollment

30 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Arms

• Experimental: Patients with suspected ICI Myocarditis
  Patients with any degree of suspicion for ICI myocarditis based on symptoms, lab tests, ECG, or imaging tests.

Primary Outcome Measure

Diagnostic accuracy for presence/absence of ICI Myocarditis [ Time Frame: 3 months ]

Central Contacts

• Jonathan Lindner, MD
  14342979442
  [email protected]

Locations (1)

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