- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03561025
Diagnostic Potential of PET/MRI in Cardiac Sarcoidosis
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Trondheim, Norway
- St Olav University Hospital, Dept Radiology and Nuclear Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
Contrast-enhanced MRI scanning after injection of 18F-FDG
Contrast-enhanced MRI scanning after injection of 18F-GE180
|
EXPERIMENTAL: 18F-GE180-PET/MRI
|
Contrast-enhanced MRI scanning after injection of 18F-FDG
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
Sponsor
Investigators
- Study Chair: Edmund Søvik, St. Olavs Hospital
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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