Somatostatin Receptor Imaging in Acute Myocarditis and Cardiac Sarcoidosis

Study Overview
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Brief Summary
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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.

Official Title
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Somatostatin Receptor Imaging in Inflammatory Heart Disease

Conditions
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Acute Myocarditis, Cardiac Sarcoidosis

Intervention / Treatment
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* Diagnostic Test: 68Ga-DOTA-TOC PET/CT
* Biological: Blood sample


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acute myocarditis<br>Included patients with clinically suspected acute myocarditis (n=30-40) will undergo a 68Ga-DOTA-TOC PET/CT and a blood sample will be taken. Furthermore, participants will undergo a contrast-enhanced MRI and endomyocardial biopsy (if clinically indicated) as part of the clinical routine work-up. | Diagnostic Test: 68Ga-DOTA-TOC PET/CT<br>* Somatostatin receptor imaging<br>Biological: Blood sample<br>* Analysis of inflammatory biomarkers<br>|
| Experimental: Cardiac sarcoidosis<br>Included patients with clinically suspected cardiac sarcoidosis (n=30-40) will undergo a 68Ga-DOTA-TOC PET/CT and a blood sample will be taken. Furthermore, participants will undergo a contrast-enhanced MRI, 18F-FDG PET/CT and endomyocardial biopsy as part of the clinical routine work-up. | Diagnostic Test: 68Ga-DOTA-TOC PET/CT<br>* Somatostatin receptor imaging<br>Biological: Blood sample<br>* Analysis of inflammatory biomarkers<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myocarditis, Cardiac sarcoidosis, Inflammatory cardiomyopathy, Cardiomyopathy, Heart disease, Cardiovascular disease, Somatostatin, 68Ga-DOTA-TOC, Positron emission tomography