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Completed

NCT Number: NCT04206163

Somatostatin Receptor Imaging in Acute Myocarditis and Cardiac Sarcoidosis

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.

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Key information

Conditions

Acute Myocarditis Cardiac Sarcoidosis Cardiomyopathies Cardiovascular Diseases Heart Diseases Myocarditis

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

68Ga-DOTA-TOC PET/CT

Diagnostic Test

Somatostatin receptor imaging

Blood sample

Biological

Analysis of inflammatory biomarkers

Primary outcomes

  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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: Completion of enrollment, approximately 5 years

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Registry information

Official study title

Somatostatin Receptor Imaging in Inflammatory Heart Disease

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Dec 20, 2019
Registry last updated
Sep 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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