Molecular Imaging for ICI Myocarditis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method to diagnose heart inflammation (myocarditis) caused by immune checkpoint inhibitors (ICIs), a type of cancer treatment. These treatments can sometimes lead to heart problems. The trial aims to determine if myocardial contrast echocardiography molecular imaging, which uses a contrast agent targeted to inflammation, can quickly identify this issue. It involves participants treated with ICIs in the past week who show signs of potential heart inflammation, such as changes in heart rhythms or specific test results. As an Early Phase 1 trial, this research seeks to understand how this new diagnostic method works in people, offering participants the chance to contribute to advancements in heart health.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on potent immunosuppressive therapy beyond corticosteroids, you may not be eligible to participate.
What prior data suggests that this ultrasound imaging technique is safe for diagnosing ICI myocarditis?
Studies on myocardial contrast echocardiography for diagnosing ICI myocarditis are still gathering safety information. This trial is in an early stage, focusing primarily on assessing safety for participants. Although detailed safety data from past studies is lacking, this phase indicates that the treatment is just beginning to be tested for safety and side effects.
Since myocardial contrast echocardiography is being tested for a new purpose, the current study aims to determine if it can safely and effectively detect heart inflammation caused by immune checkpoint inhibitors. These drugs enhance the immune system's ability to fight cancer but can sometimes lead to heart inflammation as a side effect. As the trial progresses, more specific safety information will likely emerge.12345Why are researchers excited about this trial?
Researchers are excited about myocardial contrast echocardiography molecular imaging for ICI myocarditis because it offers a novel way to visualize heart inflammation that current methods can't match. Unlike standard treatments like corticosteroids or immunosuppressive drugs that aim to reduce inflammation, this imaging technique allows for precise detection and assessment of myocarditis at a molecular level. This specificity can lead to faster and more accurate diagnoses, potentially improving patient outcomes by tailoring treatment plans more effectively.
What evidence suggests that this ultrasound imaging technique is effective for diagnosing ICI myocarditis?
Research has shown that immune checkpoint inhibitor (ICI) myocarditis, a type of heart inflammation, can lead to serious heart problems or even be fatal, with death rates ranging from 27% to 50%. Rapid diagnosis is crucial for managing these risks. This trial studies a new imaging method called myocardial contrast echocardiography to detect heart inflammation in patients with suspected ICI myocarditis. This technique uses a special contrast agent to enhance image clarity and highlight inflammation. Although data on this method remains limited, early indications suggest it could identify heart issues caused by cancer treatments like ICIs, potentially improving patient outcomes.24567
Who Is on the Research Team?
Jonathan Lindner
Principal Investigator
University of Virginia
Are You a Good Fit for This Trial?
This trial is for adults (18+) who recently received immune checkpoint inhibitor cancer therapy and now have signs of possible heart inflammation, such as abnormal blood tests, new heart rhythm problems, changes on ECG or MRI scans, or reduced heart function.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Diagnostic Imaging
Participants undergo MCE molecular imaging with Sonazoid to diagnose ICI myocarditis
Treatment
Participants receive immune suppressive therapy and undergo repeat MCE molecular imaging to evaluate response
Follow-up
Participants are monitored for cardiac function and reduction in inflammation
What Are the Treatments Tested in This Trial?
Interventions
- Myocardial contrast echocardiography molecular imaging
Trial Overview
The study is testing a special ultrasound scan of the heart using a contrast agent called Sonazoid to see if it can quickly detect inflammation in people suspected of having ICI-related myocarditis.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients with any degree of suspicion for myocarditis based on symptoms, lab tests, ECG, or imaging tests.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Virginia
Lead Sponsor
GE Healthcare
Industry Sponsor
Fotis Vlachos
GE Healthcare
Chief Marketing Officer since 2024
PhD in Molecular Biology and Biochemistry from the University of Massachusetts, MBA from the Wharton School of the University of Pennsylvania
Peter J. Arduini
GE Healthcare
Chief Executive Officer since 2022
MBA from Northwestern University, BSc in Marketing from Susquehanna University
Citations
Immune Checkpoint Inhibitor Myocarditis and Left ...
Diagnoses of myositis and myasthenia gravis–like syndrome were linked to a high in-hospital mortality rate of 60%. Histopathologic findings in ...
Immune Checkpoint Inhibitor Myocarditis
Of the patients with CMR diagnosis of ICI‐associated myocarditis, those who had midmyocardial LGE tended to have more major cardiovascular ...
Cardiac Magnetic Resonance Imaging in Immune ...
Fatal outcomes were noted in 50% of patients, again more frequent with combination immunotherapy [9]. In contrast, approximately 75% of patients ...
Multimodal Imaging of Immune Checkpoint Inhibitor Myocarditis
The reported incidence is generally low at 0.27–1% [3]. However, the rate of major cardiovascular outcomes can be as high as 40% in patients diagnosed with ICI ...
Cardiac imaging techniques for the assessment of immune ...
In this study, we systematically reviewed the studies on cardiac imaging techniques for assessing ICI-induced cardiotoxicity.
NCT07538544 | MCE Molecular Imaging for ICI Myocarditis
An adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in ...
7.
trial.medpath.com
trial.medpath.com/clinical-trial/380d32c6af22f852/nct07538544-mce-molecular-imaging-ici-myocarditisMCE Molecular Imaging for ICI Myocarditis - MedPath
Rapid diagnosis of this condition is key to reversing it. The purpose of this study is to determine whether ICI myocarditis can be diagnosed ...
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