Diagnostic Potential of PET/MRI in Cardiac Sarcoidosis
2 other identifiers
interventional
33
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 6, 2018
CompletedFirst Posted
Study publicly available on registry
June 19, 2018
CompletedStudy Start
First participant enrolled
October 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2020
CompletedNovember 18, 2020
November 1, 2020
2 years
June 6, 2018
November 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
diagnostic accuracy of a combined 18F-FDG and 18F-GE-180 PET/MRI examination for diagnosing cardiac sarcoidosis
One day after the test
Study Arms (2)
18F-FDG-PET/MRI
ACTIVE COMPARATOR18F-GE180-PET/MRI
EXPERIMENTALInterventions
Contrast-enhanced MRI scanning after injection of 18F-FDG
Contrast-enhanced MRI scanning after injection of 18F-GE180
Eligibility Criteria
You may qualify if:
- Heart department: Suspicion of myocardial sarcoidosis after contrast enhanced cardiac MRI
- Lung department: Clinically verified lung and/or mediastinal sarcoidosis
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- St. Olavs Hospitallead
- Norwegian University of Science and Technologycollaborator
- University Hospital, Essencollaborator
Study Sites (1)
St Olav University Hospital, Dept Radiology and Nuclear Medicine
Trondheim, Norway
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Edmund Søvik
St. Olavs Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2018
First Posted
June 19, 2018
Study Start
October 1, 2018
Primary Completion
October 1, 2020
Study Completion
October 1, 2020
Last Updated
November 18, 2020
Record last verified: 2020-11