FDG-PET as an Imaging Modality to Diagnose and Risk Stratify Subclinical, Imaging Negative Ici-Myocarditis

Recruiting

• Conditions: Subclinical Myocarditis; Subclinical ICI-myocarditis; ICI-Myocarditis; Hematologic Malignancy; Subclinical Immune Checkpoint Inhibitor-Induced Myocarditis; Myocarditis; Solid Malignant Tumor

• Registration Number: NCT06566209
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-20
• Study First Submitted QC: 2024-08-20
• Study First Posted: 2024-08-22
• Study Start: 2024-10-11
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-14
• Primary Completion: 2027-04-30
• Study Completion: 2027-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 hospitalization	Up to 2 years	Assessed by review of medical record for incidence of hospitalization
Incidence of arrhythmias	Up to 2 years	Assessed by reviewing medical record for incidence of cardiac arrhythmias.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States