Somatostatin Receptor Imaging in Acute Myocarditis and Cardiac Sarcoidosis

• Sponsor: Vastra Gotaland Region (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04206163
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 58.4
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myocarditis; Cardiac Sarcoidosis	Diagnostic Test: 68Ga-DOTA-TOC PET/CT; Biological: Blood sample	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Somatostatin Receptor Imaging in Inflammatory Heart Disease
• Actual Study Start Date: Jan 20, 2020
• Anticipated Primary Completion Date: Dec 1, 2024
• Anticipated Study Completion Date: Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Acute myocarditis 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.	Diagnostic Test: 68Ga-DOTA-TOC PET/CT; Somatostatin receptor imaging; Biological: Blood sample; Analysis of inflammatory biomarkers
Experimental: Cardiac sarcoidosis 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.	Diagnostic Test: 68Ga-DOTA-TOC PET/CT; Somatostatin receptor imaging; Biological: Blood sample; Analysis of inflammatory biomarkers

Outcome Measures

Primary Outcome Measures

1. 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]

2. 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]

3. 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]

4. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sahlgrenska University Hospital	Göteborg		Sweden	413 45

Sponsors and Collaborators

• Vastra Gotaland Region

Investigators

• Principal Investigator: Christian L Polte, MD, PhD, MSc, Sahlgrenska University Hospital, Sweden

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vastra Gotaland Region
• ClinicalTrials.gov Identifier: NCT04206163
• Other Study ID Numbers: 2019-001300-38
• First Posted: Dec 20, 2019
• Last Update Posted: Apr 28, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Vastra Gotaland Region: Myocarditis; Cardiac sarcoidosis; Inflammatory cardiomyopathy; Cardiomyopathy; Heart disease; Cardiovascular disease; Somatostatin; 68Ga-DOTA-TOC; Positron emission tomography
• Additional relevant MeSH terms: Myocarditis; Sarcoidosis; Edotreotide

Study Results

No Results Posted as of Apr 28, 2022