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 (STEA-MRI)

University Hospital, Clermont-Ferrand

Status: Unknown

Conditions: MRI; Liver Biopsy; Hepatic Steatosis; Quantification

Treatments: Procedure: Quantification of hepatic steatosis

Study type: Interventional

Funder types: Other

Identifiers

NCT03142698

2016-A02065-46 (Other Identifier)

CHU-317

Details and patient eligibility

About

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

Full 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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Hepatic steatosis

Experimental group

Description:

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)

Treatment:

Procedure: Quantification of hepatic steatosis