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Diagnostic Potential of PET/MRI in Cardiac Sarcoidosis

S

St. Olavs Hospital

Status

Completed

Conditions

Sarcoidosis
Cardiomyopathies

Treatments

Diagnostic Test: 18F-GE180-PET/MRI
Diagnostic Test: 18F-FDG-PET/MRI

Study type

Interventional

Funder types

Other

Identifiers

NCT03561025
2017-000331-14 (EudraCT Number)
2016/883

Details and patient eligibility

About

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.

Enrollment

33 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

33 participants in 2 patient groups

18F-FDG-PET/MRI
Active Comparator group
Treatment:
Diagnostic Test: 18F-GE180-PET/MRI
Diagnostic Test: 18F-FDG-PET/MRI
18F-GE180-PET/MRI
Experimental group
Treatment:
Diagnostic Test: 18F-GE180-PET/MRI
Diagnostic Test: 18F-FDG-PET/MRI

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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