MedTrace Logo

MCE Molecular Imaging for ICI Myocarditis

NCT07538544 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-08-12

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • GE Healthcare

    collaborator INDUSTRY

  • University of Virginia

    lead OTHER

Principal Investigators

  • Jonathan Lindner · University of Virginia

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-15
Primary Completion
2030-06-30
Completion
2030-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07538544 on ClinicalTrials.gov