This clinical trial studies the side effects on the heart from using immune checkpoint inhibitor (ICI) in treating patients with cancer. Specifically to identify if ICI affects the cardiovascular system early after therapy and if this indicates that some patients may be at an adverse risk for side effects. Diagnostic procedures such as PET/CT may help detect ICI induced inflammation of the muscle tissue of the heart (myocarditis).
Additional locations may be listed on ClinicalTrials.gov for NCT04538950.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. To determine if ICI administration causes microvascular damage/endothelial function.
II. To serve as a pilot study for larger trials to determine the prevalence of ICI-induced microvascular damage/endothelial dysfunction and specifically if it identifies patients who are at increased risk of immune related adverse events (IRAEs).
OUTLINE:
Patients receive 13NH3 intravenously (IV) and undergo positron emission tomography-computed tomography myocardial flow reserve (PET-CT MFR) over 30-60 minutes prior to ICI treatment and 4-6 weeks after the start of treatment. During the second round of imaging, patients receive regadenoson IV, 13NH3 IV, and undergo PET-CT MFR. After the second PET-CT, patients who develop myocarditis may receive fludeoxyglucose (FDG) IV and undergo PET-CT over 2-3 hours.
Lead OrganizationMayo Clinic in Rochester
Principal InvestigatorJohn P Bois
