Status:
RECRUITING
FDG-PET as an Imaging Modality to Diagnose and Risk Stratify Subclinical, Imaging Negative Ici-Myocarditis
Lead Sponsor:
Mayo Clinic
Conditions:
Subclinical Immune Checkpoint Inhibitor-Induced Myocarditis
Myocarditis
Eligibility:
All Genders
18+ years
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-myocar...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 11 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 30 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06566209
Start Date
October 11 2024
End Date
April 30 2027
Last Update
October 15 2025
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905