Immune Checkpoint Inhibitor Therapy for Cancer and Risk of Myocarditis or Cardiomyopathy
Association of Immune Checkpoint Inhibitor Therapy for Cancer With Early Myocardial Tissue and Biomarker Changes During Treatment - Implication for Risk of Myocarditis and Cardiomyopathy
Sunnybrook Health Sciences Centre
15 participants
Jun 1, 2024
OBSERVATIONAL
Conditions
Summary
Patients undergoing dual treatment with Immune checkpoint inhibitors (ICI) for various cancers, e.g. melanoma, are at increased risk of developing myocarditis and cardiomyopathy. Currently, only limited data on serial myocardial tissue changes during treatment and whether they predict outcomes are available. Cardiac MRI (CMR) is the reference standard for non-invasive myocardial volumes/function analysis and uniquely characterizes myocardial tissue. Therefore, it may help detect myocardial tissue changes during treatment and help early treatment and prevent adverse cardiac outcomes.
Eligibility
Inclusion Criteria3
- All patients 18 years of age, or older, with skin cancer and eligible for ICI treatment with a combination of a) nivolumab, b) pembrolizumab, or c) ipilimumab.
- Able to provide informed consent
- Able to travel to SHSC for cardiac imaging.
Exclusion Criteria7
- Life expectancy equal to, or less than, 12 months
- Participating in another clinical trial
- Treated with ICI in the past
- History of cardiac disease (e.g. heart failure, myocardial infarction, atrial fibrillation, unstable angina)
- Pregnant patients
- Impaired renal function (GFR equal to, or less than, 30mL/min)
- Contraindications for MRI (e.g. pacemaker).
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Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06309862