Diagnostic Potential of PET/MRI in Cardiac Sarcoidosis: A Pilot Study Combining Advanced MRI and 18F-FDG and 18F-GE180 PET of the Myocardium
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- diagnostic accuracy of a combined 18F-FDG and 18F-GE-180 PET/MRI examination for diagnosing 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Diagnostic
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported