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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03561025
Enrollment
33
Registered
2018-06-19
Start date
2018-10-01
Completion date
2020-10-01
Last updated
2020-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiomyopathies, Sarcoidosis

Keywords

Diagnostic Imaging, Positron Emission Tomography Computed Tomography, Magnetic Resonance Imaging

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.

Interventions

DIAGNOSTIC_TEST18F-FDG-PET/MRI

Contrast-enhanced MRI scanning after injection of 18F-FDG

DIAGNOSTIC_TEST18F-GE180-PET/MRI

Contrast-enhanced MRI scanning after injection of 18F-GE180

Sponsors

Norwegian University of Science and Technology
CollaboratorOTHER
University Hospital, Essen
CollaboratorOTHER
St. Olavs Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
diagnostic accuracy of a combined 18F-FDG and 18F-GE-180 PET/MRI examination for diagnosing cardiac sarcoidosisOne day after the test

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026