Somatostatin Receptor Imaging in Acute Myocarditis and Cardiac Sarcoidosis

Not Applicable

Completed

• Conditions: Cardiac Sarcoidosis; Acute Myocarditis
• Interventions: Diagnostic Test: 68Ga-DOTA-TOC PET/CT; Biological: Blood sample

• Registration Number: NCT04206163
• Lead Sponsor: Vastra Gotaland Region

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-13
• Study First Submitted QC: 2019-12-17
• Study First Posted: 2019-12-20
• Study Start: 2020-01-20
• Primary Completion: 2024-06-24
• Study Completion: 2024-06-24
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-26
• Last Update Posted: 2024-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acute myocarditis	68Ga-DOTA-TOC PET/CT	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.
Acute myocarditis	Blood sample	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.
Cardiac sarcoidosis	68Ga-DOTA-TOC PET/CT	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.
Cardiac sarcoidosis	Blood sample	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.

Primary Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

Sahlgrenska University Hospital; 🇸🇪 Göteborg, Sweden