Clinical Trials Logo
  1. Home
  2. Sarcoidosis
  3. NCT03561025
  4. Details
NCT03561025 Clinical Trial

Diagnostic Potential of PET/MRI in Cardiac Sarcoidosis

Sarcoidosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03561025
Other study ID # 2016/883
Secondary ID 2017-000331-14
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2018
Est. completion date October 1, 2020

Study information
Verified date November 2020
Source St. Olavs Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.

Recruitment information / eligibility
Status Completed
Enrollment 33
Est. completion date October 1, 2020
Est. primary completion date October 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• 18F-FDG-PET/MRI
Contrast-enhanced MRI scanning after injection of 18F-FDG
• 18F-GE180-PET/MRI
Contrast-enhanced MRI scanning after injection of 18F-GE180

Locations
Country Name City State
Norway St Olav University Hospital, Dept Radiology and Nuclear Medicine Trondheim

Sponsors (3)
Lead Sponsor Collaborator
St. Olavs Hospital Norwegian University of Science and Technology, University Hospital, Essen

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary diagnostic accuracy of a combined 18F-FDG and 18F-GE-180 PET/MRI examination for diagnosing cardiac sarcoidosis One day after the test
See also
  Status Clinical Trial Phase
Completed NCT04008069 - Sarilumab in Patients With Glucocorticoid-Dependent Sarcoidosis Phase 2
Recruiting NCT02807025 - Nasal, Tracheal and Bronchial Mucosal Lining Fluid(MLF) Sampling From Patients With Respiratory Diseases N/A
Completed NCT01615484 - Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability N/A
Completed NCT00326534 - Rickettsial Genesis to Sarcoidosis in Denmark N/A
Completed NCT00274352 - A Study of Adalimumab to Treat Sarcoidosis of the Skin Phase 2
Completed NCT00373555 - Endobronchial Ultrasonography in the Diagnosis of Sarcoidosis N/A
Recruiting NCT00470327 - A Study of the Natural Progression of Interstitial Lung Disease (ILD)
Completed NCT00512967 - The Occurence of Inflammation and Oxidative Stress in Lung Diseases N/A
Recruiting NCT01745237 - Delayed-Enhancement Cardiovascular Magnetic Resonance in Patients With Sarcoidosis
Completed NCT00369980 - Diagnostic Usefulness of Fluorine–18-α–Methyltyrosine PET in Combination With 18F-FDG in Sarcoidosis Patient N/A
Completed NCT00379275 - Eye and Immunogenetic Features of Sarcoidosis N/A
Completed NCT00366509 - Role of Helicobacter Pylori and Its Toxins in Lung and Digestive System Diseases
Completed NCT06396910 - TB and Sarcoidosis Granuloma
Completed NCT04156789 - Obstructive Sleep Apnoea in Sarcoidosis
Recruiting NCT02916459 - EBUS-TBNA vs Flex 19G EBUS-TBNA N/A
Recruiting NCT02827734 - Evaluation of Novel Lung Function Parameters in Patients With Interstitial Lung Disease (ILD)
Completed NCT02546388 - Somatostatin Receptor Imaging in Patients With Suspected Cardiac Sarcoidosis N/A
Completed NCT01687517 - Efficacy and Safety of Influenza Vaccine During Sarcoidosis Phase 3
Completed NCT01139710 - Sarcoidosis-associated Pulmonary Hypertension N/A
Terminated NCT00747461 - Interventional Cryotherapy for the Eradication of Benign Airway Disease ("ICE the BAD") Phase 4