Diagnostic Potential of PET/MRI in Cardiac Sarcoidosis

NCT ID: NCT03561025

Last Updated: 2020-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2020-10-01

Brief Summary

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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

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Conditions

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Sarcoidosis Cardiomyopathies

Keywords

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Diagnostic Imaging Positron Emission Tomography Computed Tomography Magnetic Resonance Imaging

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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18F-FDG-PET/MRI

Group Type ACTIVE_COMPARATOR

18F-FDG-PET/MRI

Intervention Type DIAGNOSTIC_TEST

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

18F-GE180-PET/MRI

Intervention Type DIAGNOSTIC_TEST

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

18F-GE180-PET/MRI

Group Type EXPERIMENTAL

18F-FDG-PET/MRI

Intervention Type DIAGNOSTIC_TEST

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

18F-GE180-PET/MRI

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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18F-FDG-PET/MRI

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

Intervention Type DIAGNOSTIC_TEST

18F-GE180-PET/MRI

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Norwegian University of Science and Technology

OTHER

Sponsor Role collaborator

University Hospital, Essen

OTHER

Sponsor Role collaborator

St. Olavs Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Edmund Søvik

Role: STUDY_CHAIR

St. Olavs Hospital

Locations

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St Olav University Hospital, Dept Radiology and Nuclear Medicine

Trondheim, , Norway

Site Status

Countries

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Norway

Other Identifiers

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2017-000331-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2016/883

Identifier Type: -

Identifier Source: org_study_id