Clinical trial NCT04206163: Somatostatin Receptor Imaging in Acute Myocarditis and Cardiac Sarcoidosis
Official title: Somatostatin Receptor Imaging in Inflammatory Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Myocarditis
Cardiac Sarcoidosis
Keywords: Myocarditis
Cardiac sarcoidosis
Inflammatory cardiomyopathy
Cardiomyopathy
Heart disease
Cardiovascular disease
Somatostatin
68Ga-DOTA-TOC
Positron emission tomography
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2019-12-20
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: Completion of enrollment, approximately 2 years
measure: 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)
timeFrame: Completion of enrollment, approximately 2 years
measure: 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)
timeFrame: Completion of enrollment, approximately 5 years
measure: 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)
timeFrame: Completion of enrollment, approximately 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
affiliation: Sahlgrenska University Hospital
name: Christian L Polte, MD, PhD, MSc
role: PRINCIPAL_INVESTIGATOR
References: