Somatostatin Receptor Imaging in Acute Myocarditis and Cardiac Sarcoidosis

Cardiac Sarcoidosis Clinical Trial

Official title:

Somatostatin Receptor Imaging in Inflammatory Heart Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04206163
• Other study ID #: 2019-001300-38
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2020
• Est. completion date: December 2024

Study information

• Verified date: April 2022
• Source: Vastra Gotaland Region
• Contact: Entela Bollano, MD, PhD
• Phone: +46-31-3421000
• Email: entela.bollano[@]vgregion.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocarditis
• Cardiac Sarcoidosis
• Myocarditis
• Sarcoidosis

Intervention

Diagnostic Test:
• 68Ga-DOTA-TOC PET/CT
Somatostatin receptor imaging

Biological:
• Blood sample
Analysis of inflammatory biomarkers

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Göteborg

Sponsors (1)

Lead Sponsor	Collaborator
Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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