Myocarditis-group diseases and Non-myocarditis-group diseases VLA-4-targeted PET diagnosis of Lymphocytic Myocarditis
Conditions
Interventions
Sponsors
Matsuoka Ken
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants must meet all of the following criteria 1. Age and group-specific eligibility: Individuals aged 18 years or older who meet either the myocarditis-group criteria (1) ((1)-1 and (1)-2), the non-myocarditis cardiomyopathy criterion (2), or the ICI-treated non-myocarditis criteria (3) ((3)-1 and (3)-2) [Myocarditis group] (1)-1 Histopathologically confirmed myocarditis, including cardiac transplant rejection (1)-2 PET/CT is expected to be feasible within 30 days of the histopathological diagnosis [Non-myocarditis group] (2) Histopathologically confirmed cardiomyopathy (3)-1 No clinical diagnosis of myocarditis (3)-2 PET/CT is expected to be feasible within 90 days after the first administration of an immune checkpoint inhibitor (ICI) 2. Ability to undergo PET/CT: The participant is able to undergo PET/CT imaging 3. Informed consent: Written informed consent for participation in this study has been obtained from the participant; or, if written consent cannot be obtained from the participant due to circumstances such as management under mechanical ventilation, consent has been obtained from a legally acceptable representative (LAR) *A legally acceptable representative refers to the participant's spouse, legal guardian, or another person equivalent thereto, in cases where communication with the participant is difficult (e.g., due to mechanical ventilation)
Exclusion criteria
Exclusion criteria: Participants will be excluded if any of the following apply 1. A history of severe hypersensitivity to any component of the PET radiopharmaceutical used in this study 2. Current treatment with a VLA-4 inhibitor and/or a VLA-4-neutralizing monoclonal antibody 3. Pregnant women or women who are suspected to be pregnant 4. Current participation in another interventional study, if undergoing the PET examination in this study is considered inappropriate. 5. Individuals deemed inappropriate for study participation by the Principal Investigator or a Subinvestigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of myocardial PET uptake, as measured by SUV (standard uptake value), between the lymphocytic myocarditis group and the non-myocarditis group. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Comparison of myocardial PET uptake (SUV) among the lymphocytic myocarditis group, the non-myocarditis group, and healthy adults (based on results from protocol No. C11-HCA2969-01). 2. (Myocarditis group only) Correlation between myocardial PET uptake and the extent of VLA-4-positive lymphocytic infiltration in histopathological specimens. 3. (Myocarditis group only) Comparison of myocardial PET uptake (SUV) across histopathological subtypes (lymphocytic, eosinophilic, giant cell myocarditis, and sarcoidosis). 4. (Lymphocytic myocarditis group only) Comparison of myocardial PET uptake (SUV) across immunophenotypic patterns (CD4-predominant, CD8-predominant, or mixed). 5. Incidence of adverse events and adverse drug reactions. | — |
Contacts
Public ContactKen Matsuoka
THE UNIVERSITY OF OSAKA HOSPITAL
Outcome results
None listed