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Diagnostic Potential of PET/MRI in Cardiac Sarcoidosis

Primary Purpose

Sarcoidosis, Cardiomyopathies

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
18F-FDG-PET/MRI
18F-GE180-PET/MRI
Sponsored by
St. Olavs Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sarcoidosis focused on measuring Diagnostic Imaging, Positron Emission Tomography Computed Tomography, Magnetic Resonance Imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St Olav University Hospital, Dept Radiology and Nuclear Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

18F-FDG-PET/MRI

18F-GE180-PET/MRI

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 6, 2018
Last Updated
November 16, 2020
Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology, University Hospital, Essen
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1. Study Identification

Unique Protocol Identification Number
NCT03561025
Brief Title
Diagnostic Potential of PET/MRI in Cardiac Sarcoidosis
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
October 1, 2020 (Actual)
Study Completion Date
October 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology, University Hospital, Essen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoidosis, Cardiomyopathies
Keywords
Diagnostic Imaging, Positron Emission Tomography Computed Tomography, Magnetic Resonance Imaging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Non-Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
18F-FDG-PET/MRI
Arm Type
Active Comparator
Arm Title
18F-GE180-PET/MRI
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
18F-FDG-PET/MRI
Intervention Description
Contrast-enhanced MRI scanning after injection of 18F-FDG
Intervention Type
Diagnostic Test
Intervention Name(s)
18F-GE180-PET/MRI
Intervention Description
Contrast-enhanced MRI scanning after injection of 18F-GE180
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edmund Søvik
Organizational Affiliation
St. Olavs Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
St Olav University Hospital, Dept Radiology and Nuclear Medicine
City
Trondheim
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Diagnostic Potential of PET/MRI in Cardiac Sarcoidosis

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