Diagnostic Potential of PET/MRI in Cardiac Sarcoidosis

November 16, 2020 updated by: St. Olavs Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

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

  • Norway
      • Trondheim, Norway
        • St Olav University Hospital, Dept Radiology and Nuclear Medicine

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 18F-FDG-PET/MRI
Diagnostic test: 18F-FDG-PET/MRI
Contrast-enhanced MRI scanning after injection of 18F-FDG
Diagnostic test: 18F-GE180-PET/MRI
Contrast-enhanced MRI scanning after injection of 18F-GE180
EXPERIMENTAL: 18F-GE180-PET/MRI
Diagnostic test: 18F-FDG-PET/MRI
Contrast-enhanced MRI scanning after injection of 18F-FDG
Diagnostic test: 18F-GE180-PET/MRI
Contrast-enhanced MRI scanning after injection of 18F-GE180

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
One day after the test

Collaborators and Investigators

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

Sponsor

St. Olavs Hospital

Collaborators

Norwegian University of Science and Technology
University Hospital, Essen

Investigators

  • Study Chair: Edmund Søvik, St. Olavs Hospital

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)

October 1, 2018

Primary Completion (ACTUAL)

October 1, 2020

Study Completion (ACTUAL)

October 1, 2020

Study Registration Dates

First Submitted

June 6, 2018

First Submitted That Met QC Criteria

June 6, 2018

First Posted (ACTUAL)

June 19, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 18, 2020

Last Update Submitted That Met QC Criteria

November 16, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016/883
  • 2017-000331-14 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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