Diagnostic Potential of PET/MRI in Cardiac Sarcoidosis | NCT03561025

Studies
Diagnostic Potential of PET/MRI in Cardiac Sarcoidosis

NCT03561025

Sponsor

St. Olavs Hospital

Status

Completed

Last Update Posted

Nov 18, 2020Actual

Enrollment

33Actual

Phase

Not Applicable

Conditions

Sarcoidosis
Cardiomyopathies

Interventions

18F-FDG-PET/MRI
18F-GE180-PET/MRI

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2017-000331-14	EudraCT Number

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2018Actual

Primary Completion Date

Oct 1, 2020Actual

Completion Date

Oct 1, 2020Actual

First Submitted Date

Jun 6, 2018

First Submission Date that Met QC Criteria

Jun 6, 2018

First Posted Date

Jun 19, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 16, 2020

Last Update Posted Date

Nov 18, 2020Actual

Name	Class
Norwegian University of Science and Technology	OTHER
University Hospital, Essen	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

33Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
18F-FDG-PET/MRI	Active Comparator		Diagnostic Test: 18F-FDG-PET/MRI Diagnostic Test: 18F-GE180-PET/MRI
18F-GE180-PET/MRI	Experimental		Diagnostic Test: 18F-FDG-PET/MRI Diagnostic Test: 18F-GE180-PET/MRI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
18F-FDG-PET/MRI	Diagnostic Test	Contrast-enhanced MRI scanning after injection of 18F-FDG	18F-FDG-PET/MRI 18F-GE180-PET/MRI

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Edmund Søvik	St. Olavs Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St Olav University Hospital, Dept Radiology and Nuclear Medicine		Trondheim			Norway

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012507	Sarcoidosis
D009202	Cardiomyopathies

Ancestor Terms

ID	Term
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D006968	Hypersensitivity, Delayed

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