Diagnostic Potential of PET/MRI in Cardiac Sarcoidosis

Study Overview
=================
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.

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

Conditions
-----------------
Sarcoidosis, Cardiomyopathies

Intervention / Treatment
-----------------
* Diagnostic Test: 18F-FDG-PET/MRI
* Diagnostic Test: 18F-GE180-PET/MRI


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 18F-FDG-PET/MRI<br> | Diagnostic Test: 18F-FDG-PET/MRI<br>* Contrast-enhanced MRI scanning after injection of 18F-FDG<br>Diagnostic Test: 18F-GE180-PET/MRI<br>* Contrast-enhanced MRI scanning after injection of 18F-GE180<br>|
| Experimental: 18F-GE180-PET/MRI<br> | Diagnostic Test: 18F-FDG-PET/MRI<br>* Contrast-enhanced MRI scanning after injection of 18F-FDG<br>Diagnostic Test: 18F-GE180-PET/MRI<br>* Contrast-enhanced MRI scanning after injection of 18F-GE180<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnostic accuracy of a combined 18F-FDG and 18F-GE-180 PET/MRI examination for diagnosing cardiac sarcoidosis |  | One day after the test | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diagnostic Imaging, Positron Emission Tomography Computed Tomography, Magnetic Resonance Imaging