RECRUITINGOBSERVATIONAL
FDG-PET as an Imaging Modality to Diagnose and Risk Stratify Subclinical, Imaging Negative Ici-Myocarditis
Positron Emission Tomography for the Detection of Subclinical Immune Checkpoint Inhibitor-Induced Myocarditis (PET-SIM): A Prospective, Single Center, Single Arm, Open Label Pilot Study
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- Age ≥18 years at the time of signing willing to sign a consent form
- 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) willing to sign a consent form 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.
Who Should NOT Join This Trial:
- 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 willing to sign a consent form
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DEVICE
Fluorodeoxyglucose - Positron Emission Tomography (FDG-PET)
Receive 18F-FDG PET/CT
Locations (1)
Mayo Clinic in Rochester
Rochester, Minnesota, United States