Somatostatin Receptor Imaging in Acute Myocarditis and Cardiac Sarcoidosis

NCT04206163 | Completed DMC

• 1 other identifier: 2019-001300-38
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myocarditis; Cardiac Sarcoidosis

Keywords

Myocarditis; Cardiac sarcoidosis; Inflammatory cardiomyopathy; Cardiomyopathy; Heart disease; Cardiovascular disease; Somatostatin; 68Ga-DOTA-TOC; Positron emission tomography

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

Study Arms (2)

Acute myocarditis

EXPERIMENTAL

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; Biological: Blood sample

Cardiac sarcoidosis

EXPERIMENTAL

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; Biological: Blood sample

Interventions

68Ga-DOTA-TOC PET/CT DIAGNOSTIC_TEST

Somatostatin receptor imaging

Acute myocarditis; Cardiac sarcoidosis

Blood sample BIOLOGICAL

Analysis of inflammatory biomarkers

Acute myocarditis; Cardiac sarcoidosis

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

Location

MeSH Terms

Conditions

Myocarditis; Cardiomyopathies; Heart Diseases; Cardiovascular Diseases

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Christian L Polte, MD, PhD, MSc

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2019
• First Posted: December 20, 2019
• Study Start: January 20, 2020
• Primary Completion: June 24, 2024
• Study Completion: June 24, 2024
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)