Hematologic Malignancy, ICI-Myocarditis, Myocarditis, Solid Malignant Tumor, Subclinical ICI-myocarditis, Subclinical Immune Checkpoint Inhibitor-Induced Myocarditis, Subclinical Myocarditis
Conditions
Brief summary
The purpose of this pilot study is to evaluate Fluorodeoxyglucose - Positron Emission Tomography (FDG-PET) as an imaging modality to diagnose and risk stratify subclinical, imaging negative ICI-myocarditis, and to determine whether subclinical ICI-induced myocarditis is a distinct and clinically relevant entity with a risk of progression to fulminant myocarditis.
Interventions
DEVICEFluorodeoxyglucose - Positron Emission Tomography (FDG-PET)
Receive 18F-FDG PET/CT
Sponsors
Mayo Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years at the time of signing informed consent * Any solid or hematologic malignancy undergoing treatment with ICI (either as a single agent or in combination with others) * Ambulatory and able to complete a 48-72 hour high fat and low carbohydrate diet with 18 hours fasting (PET diet), 18F-FDG PET/CT scanning, as well as 13N-ammonia PET-CT myocardial perfusion imaging (part of the routine protocol of the investigation). These two studies will be done as part of the same imaging set. * Willing to return to Mayo Clinic for ongoing follow-up * Left ventricular ejection fraction (LVEF) ≥45% * Cardiac MRI (CMR) without conclusive evidence of inflammation, coronary assessment available (either via cardiac computed tomography angiography, CCTA, or via coronary angiogram) Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
Exclusion criteria
* Fulminant myocarditis requiring steroid therapy * CMR with definitive evidence of myocarditis * Clinical presentation consistent with acute coronary syndrome (wall motion abnormalities consistent with a specific coronary distribution, coronary angiogram with a culprit lesion identified, patients requiring revascularization either with percutaneous coronary interventions or coronary artery bypass grafting). * Patients unable to provide informed consent * Patients unable to complete the diet preparation protocol * Pregnancy (all women of child-bearing age and potential will have a negative pregnancy test within 48 hours of the PET/CT at screen and 6-month visit) * Breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presennce of inflammation or scarring | Baseline; Up to 7 months | Assessed by reviewing 18F-FDG PET/CT imaging for presence of inflammation, progression/regression of inflammation or scarring. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of hospitalization | Up to 2 years | Assessed by review of medical record for incidence of hospitalization |
| Cardiovascular Intensive Care Unit (CICU) Level of Care Days | Up to 2 years | Assessed by reviewing medical record for number of days, if any, of CICU care. |
| Incidence of arrhythmias | Up to 2 years | Assessed by reviewing medical record for incidence of cardiac arrhythmias. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMartin G. Rodriguez-Porcel, MD
Mayo Clinic in Rochester
Outcome results
None listed