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Completed

NCT Number: NCT03561025

Diagnostic Potential of PET/MRI in Cardiac Sarcoidosis

The aim of the study is to find better and more specific non-invasive methods to diagnose and stage cardiac sarcoidosis with the use of advanced imaging modalities, simultaneous 3T MRI and PET. Cardiac sarcoidosis is a disease of possibly fatal outcome in young people. The use of a combined PET/MRI system with 18F-FDG and a new inflammation-tracer (18F-GE180) can become a future game changer.

Sarcoid induced focal inflammation in myocardium should show high 18F-GE180 uptake. 18F-GE180 PET scans will give reliable data about inflammatory sarcoidosis activity in the myocardium. 18F-GE180 PET is expected to improve diagnostic accuracy compared to 18F-FDG-PET and/or contrast enhanced MRI.

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Key information

Conditions

Sarcoidosis Cardiomyopathies Cardiovascular Diseases Heart Diseases Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Delayed Immune System Diseases Lymphatic Diseases Lymphoproliferative Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Olav University Hospital, Dept Radiology and Nuclear Medicine

Trondheim, Norway

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Heart department: Suspicion of myocardial sarcoidosis after contrast enhanced cardiac MRI
  • Lung department: Clinically verified lung and/or mediastinal sarcoidosis

Exclusion criteria

  • Known malignancies
  • Treatment for sarcoidosis started
  • Severe arrhythmia
  • Patients with pacemakers or defibrillator
  • Claustrophobia
  • Known alcohol or drug abuse
  • Kidney failure (eGFR < 30)
  • Weight > 120 kg
  • Diabetes Mellitus type I and II
  • Patients that take immunosuppressive or immunomodulatory medication for any reason

Treatment and study plan

18F-FDG-PET/MRI

Diagnostic Test

Contrast-enhanced MRI scanning after injection of 18F-FDG

18F-GE180-PET/MRI

Diagnostic Test

Contrast-enhanced MRI scanning after injection of 18F-GE180

Primary outcomes

  1. diagnostic accuracy of a combined 18F-FDG and 18F-GE-180 PET/MRI examination for diagnosing cardiac sarcoidosis

    Time frame: One day after the test

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Collaborators

  • Norwegian University of Science and Technology
  • University Hospital, Essen

Registry information

Official study title

Diagnostic Potential of PET/MRI in Cardiac Sarcoidosis: A Pilot Study Combining Advanced MRI and 18F-FDG and 18F-GE180 PET of the Myocardium

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 19, 2018
Registry last updated
Nov 18, 2020

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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