SarcoidosisNCT03561025
Diagnostic Potential of PET/MRI in Cardiac Sarcoidosis
A study testing 18F-FDG-PET/MRI and 18F-GE180-PET/MRI in people with Sarcoidosis and Cardiomyopathies, run by St. Olavs Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoidosis, Cardiomyopathies
- What is being tested?
- 18F-FDG-PET/MRI and 18F-GE180-PET/MRI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteNorway
- Study dates
- 1 Oct 2018to 1 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Heart department: Suspicion of myocardial sarcoidosis after contrast enhanced cardiac MRI
- Lung department: Clinically verified lung and/or mediastinal sarcoidosis
Who cannot join
- Known malignancies
- Treatment for sarcoidosis started
- Severe arrhythmia
- Patients with pacemakers or defibrillator
- Claustrophobia
- Known alcohol or drug abuse
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- Kidney failure (eGFR < 30)
- Weight > 120 kg
- Diabetes Mellitus type I and II
- Patients that take immunosuppressive or immunomodulatory medication for any reason
Trial locations and contacts
1 site in 1 country.
Norway1 site
St Olav University Hospital, Dept Radiology and Nuclear Medicine
Trondheim
About this study
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
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.
- Conditions
- Sarcoidosis, Cardiomyopathies
- Being tested
- 18F-FDG-PET/MRI, 18F-GE180-PET/MRI
- Keywords
- Diagnostic Imaging, Positron Emission Tomography Computed Tomography, Magnetic Resonance Imaging
- Medical subject headings
- Sarcoidosis, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FDG-PET/MRIDiagnostic test
Contrast-enhanced MRI scanning after injection of 18F-FDG
18F-GE180-PET/MRIDiagnostic test
Contrast-enhanced MRI scanning after injection of 18F-GE180
| Study group | Role | What they receive |
|---|---|---|
| 18F-FDG-PET/MRI | Active comparator | Not described Receives: Diagnostic Test: 18F-FDG-PET/MRI; Diagnostic Test: 18F-GE180-PET/MRI |
| 18F-GE180-PET/MRI | Experimental | Not described Receives: Diagnostic Test: 18F-FDG-PET/MRI; Diagnostic Test: 18F-GE180-PET/MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic accuracy of a combined 18F-FDG and 18F-GE-180 PET/MRI examination for diagnosing cardiac sarcoidosis
Measured: One day after the test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start1 Oct 2018
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcoidosisStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology, University Hospital, Essen
- Responsible party
- Sponsor
- Investigators
- Edmund Søvik, Study chair, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03561025
- Sponsor's protocol ID
- 2016/883
- Other IDs
- 2017-000331-14, 2017
- Status last verified
- Nov 2020
- First submitted
- 6 Jun 2018
- Last updated
- 18 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03561025
- Acronym / sponsor ID
- 2016/883
- Conditions
- Sarcoidosis, Cardiomyopathies
- Keywords
- Diagnostic Imaging, Positron Emission Tomography Computed Tomography, Magnetic Resonance Imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology, University Hospital, Essen
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 19 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 18F-FDG-PET/MRI | Active comparator | Diagnostic Test: 18F-FDG-PET/MRI, Diagnostic Test: 18F-GE180-PET/MRI |
| 18F-GE180-PET/MRI | Experimental | Diagnostic Test: 18F-FDG-PET/MRI, Diagnostic Test: 18F-GE180-PET/MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Heart department: Suspicion of myocardial sarcoidosis after contrast enhanced cardiac MRI
- Lung department: Clinically verified lung and/or mediastinal sarcoidosis
Key exclusion criteria (10 listed)
- Known malignancies
- Treatment for sarcoidosis started
- Severe arrhythmia
- Patients with pacemakers or defibrillator
- Claustrophobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-FDG-PET/MRIContrast-enhanced MRI scanning after injection of 18F-FDG | Diagnostic test | 18F-FDG-PET/MRI, 18F-GE180-PET/MRI |
| 18F-GE180-PET/MRIContrast-enhanced MRI scanning after injection of 18F-GE180 | Diagnostic test | 18F-FDG-PET/MRI, 18F-GE180-PET/MRI |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edmund Søvik study chair
St. Olavs Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-FDG-PET/MRI and 18F-GE180-PET/MRI in people with Sarcoidosis and Cardiomyopathies, run by St. Olavs Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2020; AzTrials last refreshed its copy on 8 Nov 2026.