MCE Molecular Imaging for ICI Myocarditis

MCE Molecular Imaging in ICI Myocarditis

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Immune Checkpoint Inhibitor Myocarditis
• Intervention / Treatment: Diagnostic test: Myocardial contrast echocardiography molecular imaging for inflammation

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Jonathan Lindner, MD; Phone Number: 14342979442; Email: jlindner@virginia.edu

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia
      • Contact: Jonathan Lindner, MD; Phone Number: 14342979442; Email: jlindner@virginia.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with suspected ICI Myocarditis; Patients with any degree of suspicion for ICI myocarditis based on symptoms, lab tests, ECG, or imaging tests.	Diagnostic test: Myocardial contrast echocardiography molecular imaging for inflammation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy for presence/absence of ICI Myocarditis	The ability of of MCE molecular imaging with Sonazoid to diagnose ICI myocarditis will be determined by comparing to a gold standard (either cardiac MRI or myocardial biopsy).	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response to therapy	The ability of MCE molecular imaging to detect a reduction in inflammation as a response to immune suppressive therapy will be evaluated by repeat MCE molecular imaging 14 days after starting immune suppressive therapy, and evaluation of cardiac function at 3 months.	3 month

Collaborators and Investigators

• Sponsor: University of Virginia
• Collaborators: GE Healthcare
• Investigators: Principal Investigator: Jonathan Lindner, University of Virginia

Publications and helpful links

General Publications

• Mott B, Packwood W, Xie A, Belcik JT, Taylor RP, Zhao Y, Davidson BP, Lindner JR. Echocardiographic Ischemic Memory Imaging Through Complement-Mediated Vascular Adhesion of Phosphatidylserine-Containing Microbubbles. JACC Cardiovasc Imaging. 2016 Aug;9(8):937-46. doi: 10.1016/j.jcmg.2015.11.031. Epub 2016 Jun 15.
• Davidson BP, Hodovan J, Layoun ME, Golwala H, Zahr F, Lindner JR. Echocardiographic Ischemic Memory Molecular Imaging for Point-of-Care Detection of Myocardial Ischemia. J Am Coll Cardiol. 2021 Nov 16;78(20):1990-2000. doi: 10.1016/j.jacc.2021.08.068.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): July 1, 2030

Study Registration Dates

• First Submitted: April 13, 2026
• First Submitted That Met QC Criteria: April 13, 2026
• First Posted (Actual): April 20, 2026

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Immune checkpoint inhibitor; Myocarditis; Molecular imaging; Myocardial contrast echocardiography
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Cardiomyopathies; Myocarditis
• Other Study ID Numbers: HSR 303588

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified raw data will be provided upon request as outlined by the Data Sharing Plan developed in the course of NIH application.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No