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

Not Applicable

• Conditions: MRI; Hepatic Steatosis; Liver Biopsy; Quantification
• Interventions: Procedure: Quantification of hepatic steatosis

• Registration Number: NCT03142698
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief Summary

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

Detailed Description

Hepatic steatosis is an increasingly frequent pathology, which can lead to severe complications (Cirrhosis, Hepatocellular Carcinoma).

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

Study Timeline

• Study First Submitted: 2017-04-13
• Status Verified: 2017-05
• Study Start: 2017-05
• Study First Submitted QC: 2017-05-04
• Last Update Submitted: 2017-05-04
• Study First Posted: 2017-05-05
• Last Update Posted: 2017-05-05
• Primary Completion: 2018-03
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• patients undergoing hepatic biopsy (trans-parietal or trans-jugular) in the context of liver disease
• signature of written consent

Exclusion Criteria

• Contra-indications to MRI
• Refusal of protocol
• underage patients and protected adults

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hepatic steatosis	Quantification of 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)

Primary Outcome Measures

Name	Time	Method
Correlation coefficient - for each quantitative MRI variable studied - with the histological score of hepatic steatosis.	at day 1	Correlation coefficient - for each quantitative MRI variable studied - with the histological score of hepatic steatosis.

Secondary Outcome Measures

Name	Time	Method
Measurement of intrahepatic fibrosis	at day 1
Measurement of intrahepatic iron	at day 1
Measurement of fat in different hepatic segments	at day 1	(MRI )
Concordance between observers	at day 1	(for MRI measurements)

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France