RecruitingNCT06566209

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

Sponsor

Mayo Clinic

Enrollment

30 participants

Start Date

Oct 11, 2024

Study Type

OBSERVATIONAL

Conditions

Hematologic Malignancy Myocarditis Subclinical Immune Checkpoint Inhibitor-Induced Myocarditis ICI-Myocarditis Solid Malignant Tumor Subclinical Myocarditis Subclinical ICI-myocarditis

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

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 Criteria7

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