Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low/slow accrual (change in standard treatment practice)
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| ICI-Myocarditis | — | UNRESOLVED | — |
| Myocarditis | — | UNRESOLVED | — |
| Solid Malignant Tumor | — | UNRESOLVED | — |
| Subclinical ICI-myocarditis | — | UNRESOLVED | — |
| Subclinical Immune Checkpoint Inhibitor-Induced Myocarditis | — | UNRESOLVED | — |
| Subclinical Myocarditis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluorodeoxyglucose - Positron Emission Tomography (FDG-PET) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Experimental FDG PET/CT
- description
- Patients undergo 18F-FDG and 13N-ammonia PET/CT scan, blood sample collection and have their medical records reviewed on study.
- interventionNames
- Device: Fluorodeoxyglucose - Positron Emission Tomography (FDG-PET)
Primary outcomes (1)
- measure
- Presennce of inflammation or scarring
- timeFrame
- Baseline; Up to 7 months
- description
- Assessed by reviewing 18F-FDG PET/CT imaging for presence of inflammation, progression/regression of inflammation or scarring.
Secondary outcomes (3)
- measure
- Incidence of hospitalization
- timeFrame
- Up to 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available