Somatostatin Receptor Imaging in Acute Myocarditis and Cardiac Sarcoidosis

Vastra Gotaland Region

Status: Completed

Conditions: Acute Myocarditis; Cardiac Sarcoidosis

Treatments: Diagnostic Test: 68Ga-DOTA-TOC PET/CT; Biological: Blood sample

Study type: Interventional

Funder types: Other

Identifiers

NCT04206163

2019-001300-38

Details and patient eligibility

About

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.

Enrollment: 78 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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78 participants in 2 patient groups

Acute myocarditis

Experimental group

Description:

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.

Treatment:

Biological: Blood sample

Diagnostic Test: 68Ga-DOTA-TOC PET/CT

Cardiac sarcoidosis

Experimental group

Description:

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.

Treatment:

Biological: Blood sample

Diagnostic Test: 68Ga-DOTA-TOC PET/CT