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

MRI Clinical Trial

— STEA-MRI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03142698
• Other study ID #: CHU-317
• Secondary ID: 2016-A02065-46
• Status: Recruiting
• Phase: N/A
• First received: April 13, 2017
• Last updated: May 4, 2017
• Start date: May 2017
• Est. completion date: September 2018

Study information

• Verified date: May 2017
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrnd.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Hepatic Steatosis
• Liver Biopsy
• MRI
• Quantification

Intervention

Procedure:
• Quantification of hepatic steatosis
Quantification of hepatic steatosis (histology, and in MRI)

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation coefficient - for each quantitative MRI variable studied - with the histological score of hepatic steatosis.	Correlation coefficient - for each quantitative MRI variable studied - with the histological score of hepatic steatosis.	at day 1
Secondary	Measurement of intrahepatic iron		at day 1
Secondary	Measurement of intrahepatic fibrosis		at day 1
Secondary	Measurement of fat in different hepatic segments	(MRI )	at day 1
Secondary	Concordance between observers	(for MRI measurements)	at day 1