Somatostatin Receptor Imaging in Acute Myocarditis and Cardiac Sarcoidosis

N/ACompletedNCT04206163

Vastra Gotaland Region78 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Acute Myocarditis Cardiac Sarcoidosis

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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)

Time frame: 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)

Time frame: 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)

Time frame: 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)