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

Mayo Clinic1 site in 1 country30 target enrollmentOctober 11, 2024

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

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Subclinical Immune Checkpoint Inhibitor-Induced Myocarditis
Sponsor: Mayo Clinic
Enrollment: 30
Locations: 1
Primary Endpoint: Presennce of inflammation or scarring
Status: Recruiting
Last Updated: 6 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 11, 2024

End Date

April 30, 2027

Last Updated

6 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Mayo Clinic

Responsible Party

Sponsor

Eligibility Criteria

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