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

Launched by MAYO CLINIC · Aug 20, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a special type of imaging called Fluorodeoxyglucose-Positron Emission Tomography (FDG-PET) to help diagnose a condition called subclinical immune checkpoint inhibitor-induced myocarditis (ICI-myocarditis). This condition can occur in some patients receiving certain cancer treatments and may not show clear signs on regular imaging tests. The study aims to see if FDG-PET can identify this condition early and help understand its potential risks, including whether it can progress to more serious heart issues.

To participate, individuals must be at least 18 years old, currently being treated for cancer with certain therapies, and have specific heart health indicators, such as elevated troponin levels. Participants will need to follow a special diet and undergo imaging tests at the Mayo Clinic. Throughout the study, they will receive monitoring and follow-up care. It's important to note that individuals with certain heart conditions or those on high doses of steroids are not eligible for this trial. This study is currently recruiting participants, so if you or someone you know fits the criteria, it could be an opportunity to help advance our understanding of this serious condition.

Gender

ALL

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