Diagnostic Potential of PET/MRI in Cardiac Sarcoidosis

Not Applicable

Completed

• Conditions: Sarcoidosis; Cardiomyopathies
• Interventions: Diagnostic Test: 18F-FDG-PET/MRI; Diagnostic Test: 18F-GE180-PET/MRI

• Registration Number: NCT03561025
• Lead Sponsor: St. Olavs Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-06
• Study First Submitted QC: 2018-06-06
• Study First Posted: 2018-06-19
• Study Start: 2018-10-01
• Primary Completion: 2020-10-01
• Study Completion: 2020-10-01
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-16
• Last Update Posted: 2020-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
18F-FDG-PET/MRI	18F-FDG-PET/MRI	-
18F-FDG-PET/MRI	18F-GE180-PET/MRI	-
18F-GE180-PET/MRI	18F-FDG-PET/MRI	-
18F-GE180-PET/MRI	18F-GE180-PET/MRI	-

Primary Outcome Measures

Name	Time	Method
diagnostic accuracy of a combined 18F-FDG and 18F-GE-180 PET/MRI examination for diagnosing cardiac sarcoidosis	One day after the test

Trial Locations

Locations (1)

St Olav University Hospital, Dept Radiology and Nuclear Medicine; 🇳🇴 Trondheim, Norway