MCE Molecular Imaging for ICI Myocarditis

NCT07538544 | Not Yet Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: HSR 303588
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Immune Checkpoint Inhibitor Myocarditis

Keywords

Myocarditis; Immune checkpoint inhibitor; Myocardial contrast echocardiography; Molecular imaging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Response to therapy

  3 month

Study Arms (1)

Patients with suspected ICI Myocarditis

EXPERIMENTAL

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

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.

Patients with suspected ICI Myocarditis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.)

Sponsors & Collaborators

• University of Virginia: lead
• GE Healthcare: collaborator

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Related Publications (2)

• 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.

  PMID: 27318722 BACKGROUND

• 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.

  PMID: 34763776 BACKGROUND

MeSH Terms

Conditions

Myocarditis

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases

Study Officials

• Jonathan Lindner

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan Lindner, MD

CONTACT

14342979442; jlindner@virginia.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 20, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)