Evaluation of 4 MRI Methods (PDFF 3, 6 and 11 Gradient Echoes and Spectroscopy) Compared to the Reference Method (Liver Biopsy) in Quantification of Hepatic Steatosis
NCT ID: NCT03142698
Last Updated: 2017-05-05
Study Results
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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UNKNOWN
NA
60 participants
INTERVENTIONAL
2017-05-31
2018-09-30
Brief Summary
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Detailed Description
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The poor quantification of steatosis by ultrasound or scanning and the invasiveness of the reference method (liver biopsy) make MRI a measurement tool of choice.
Recent techniques such as proton density measurement with several echoes or spectroscopy are increasingly used for the measurement of steatosis.
At the time of the development of therapeutics to reduce fatty liver disease, the use of MRI seems an interesting alternative for longitudinal follow-up in these patients.
Our study aims to ensure the reliability of these different MRI techniques for accurate quantification of liver steatosis and to compare them.
* Measurement and influence of hepatic fibrosis
* Measurement and influence of intrahepatic iron
* Influence of intercurrent liver disease
* Comparison of the fat measurement of the different hepatic segments
* Reproducibility by measurement of inter-observer concordance
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Hepatic steatosis
Evaluation of different techniques in quantification of hepatic steatosis by MRImaging (PDFF 3, 6 and 11 gradient echoes and Spectroscopy) compared to the histological method (reference)
Quantification of hepatic steatosis
Quantification of hepatic steatosis (histology, and in MRI)
Interventions
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Quantification of hepatic steatosis
Quantification of hepatic steatosis (histology, and in MRI)
Eligibility Criteria
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Inclusion Criteria
* signature of written consent
Exclusion Criteria
* Refusal of protocol
* underage patients and protected adults
18 Years
90 Years
ALL
No
Sponsors
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University Hospital, Clermont-Ferrand
OTHER
Responsible Party
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Principal Investigators
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Louis BOYER
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Clermont-Ferrand
Locations
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CHU Clermont-Ferrand
Clermont-Ferrand, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2016-A02065-46
Identifier Type: OTHER
Identifier Source: secondary_id
CHU-317
Identifier Type: -
Identifier Source: org_study_id
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