Somatostatin Receptor Imaging in Acute Myocarditis and Cardiac Sarcoidosis

September 26, 2024 updated by: Vastra Gotaland Region

Somatostatin Receptor Imaging in Inflammatory Heart Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Göteborg, Sweden, 413 45
        • Sahlgrenska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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)
Time Frame: Completion of enrollment, approximately 2 years
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)
Time Frame: Completion of enrollment, approximately 5 years
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)
Time Frame: Completion of enrollment, approximately 5 years
Completion of enrollment, approximately 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vastra Gotaland Region

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2020

Primary Completion (Actual)

June 24, 2024

Study Completion (Actual)

June 24, 2024

Study Registration Dates

First Submitted

December 13, 2019

First Submitted That Met QC Criteria

December 17, 2019

First Posted (Actual)

December 20, 2019

Study Record Updates

Last Update Posted (Actual)

September 27, 2024

Last Update Submitted That Met QC Criteria

September 26, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-001300-38

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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