Acute Myocarditis, Cardiac Sarcoidosis
Conditions
Keywords
Myocarditis, Cardiac sarcoidosis, Inflammatory cardiomyopathy, Cardiomyopathy, Heart disease, Cardiovascular disease, Somatostatin, 68Ga-DOTA-TOC, Positron emission tomography
Brief summary
This prospective imaging study investigates the diagnostic ability of Gallium-68 DOTA-TOC (68Ga-DOTA-TOC) positron emission tomography/computed tomography (PET/CT) in the clinical work-up of patients with 1) clinically suspected acute myocarditis (n=30-40) and 2) clinically suspected cardiac sarcoidosis (n=30-40) using clinical diagnostic criteria as well as endomyocardial biopsy as reference. Furthermore, 68Ga-DOTA-TOC PET/CT findings will be compared with results from contrast-enhanced magnetic resonance imaging (MRI) and in case of cardiac sarcoidosis even Fluorine-18 fluorodeoxyglucose (18F-FDG) PET/CT, which are both performed as part of the clinical routine work-up.
Interventions
DIAGNOSTIC_TEST68Ga-DOTA-TOC PET/CT
Somatostatin receptor imaging
BIOLOGICALBlood sample
Analysis of inflammatory biomarkers
Sponsors
Vastra Gotaland Region
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Willingness to participate in the study * Provision of written informed consent * All patients between the age of 18 and 85 of both genders * Newly clinically suspected acute myocarditis or newly clinically suspected cardiac sarcoidosis with or without known extra-cardiac sarcoid
Exclusion criteria
* Pregnancy or lactation * Severe obesity (limited by the scanner) * Other known significant cardiac disease, including previous myocarditis * Known tumour disease, especially (neuro)endocrine tumours * Terminal disease(s), advanced psychiatric disease and/or significant dementia * Recent or current immunosuppressive treatment * Recent or current somatostatin analogue (octreotide) therapy * Known relative/absolute contraindications for contrast-enhanced MRI and/or PET/CT imaging * Known contraindications for endomyocardial biopsy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity of 68Ga-DOTA-TOC PET/CT versus contrast-enhanced MRI in patients with clinically suspected acute myocarditis (using clinical diagnostic criteria as well as endomyocardial biopsy as reference) | Completion of enrollment, approximately 2 years |
| Specificity of 68Ga-DOTA-TOC PET/CT versus contrast-enhanced MRI in patients with clinically suspected acute myocarditis (using clinical diagnostic criteria as well as endomyocardial biopsy as reference) | Completion of enrollment, approximately 2 years |
| Sensitivity of 68Ga-DOTA-TOC PET/CT versus contrast-enhanced MRI and 18F-FDG PET/CT in patients with clinically suspected cardiac sarcoidosis (using clinical diagnostic criteria as well as endomyocardial biopsy as reference) | Completion of enrollment, approximately 5 years |
| Specificity of 68Ga-DOTA-TOC PET/CT versus contrast-enhanced MRI and 18F-FDG PET/CT in patients with clinically suspected cardiac sarcoidosis (using clinical diagnostic criteria as well as endomyocardial biopsy as reference) | Completion of enrollment, approximately 5 years |
Countries
Sweden
Outcome results
None listed