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

Not yet recruiting

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

• Registration Number: NCT06566209
• Lead Sponsor: Mayo Clinic

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-8-20
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Inclusion Criteria:<br><br> - Age =18 years at the time of signing informed consent<br><br> - Any solid or hematologic malignancy undergoing treatment with ICI (either as a<br> single agent or in combination with others)<br><br> - Ambulatory and able to complete 2-day high fat and low carbohydrate diet with 18<br> hours fasting (PET diet), 18F-FDG PET/CT scanning, as well as 13N-ammonia PET-CT<br> myocardial perfusion imaging (part of the routine protocol of the investigation).<br> These two studies will be done as part of the same imaging set.<br><br> - Willing to return to Mayo Clinic for ongoing follow-up<br><br> - Elevated troponin T levels (=100 ng/L)<br><br> - Left ventricular ejection fraction (LVEF) =50%<br><br> - Cardiac MRI (CMR) without evidence of inflammation, coronary assessment available<br> (either via cardiac computed tomography angiography, CCTA, or via coronary<br> angiogram) Informed consent obtained before any trial-related activities.<br> Trial-related activities are any procedures that are carried out as part of the<br> trial, including activities to determine suitability for the trial.<br><br>Exclusion Criteria:<br><br> - Chest pain<br><br> - Fulminant myocarditis requiring steroid therapy<br><br> - Cardiac MRI (CMR) with evidence of inflammation<br><br> - On high doses of steroid treatment for other causes<br><br> - Clinical presentation consistent with acute coronary syndrome (wall motion<br> abnormalities consistent with a specific coronary distribution, coronary angiogram<br> with a culprit lesion identified, patients requiring revascularization either with<br> percutaneous coronary interventions or coronary artery bypass grafting).<br><br> - Patients unable to provide informed consent<br><br> - Patients unable to complete the diet preparation protocol<br><br> - Pregnancy (all women of child-bearing age and potential will have a negative<br> pregnancy test within 48 hours of the PET/CT at screen and 6-month visit)<br><br> - Breastfeeding

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presennce of inflammation or scarring

Secondary Outcome Measures

Name	Time	Method
Incidence of hospitalization;Cardiovascular Intensive Care Unit (CICU) Level of Care Days;Incidence of arrhythmias