STEA-MRI: 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

• Sponsor: University Hospital, Clermont-Ferrand (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03142698
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 16
• Patients Per Site Per Month: 3.7

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Hepatic Steatosis; MRI; Liver Biopsy; Quantification	Procedure: Quantification of hepatic steatosis	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• 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
• Anticipated Study Start Date: May 1, 2017
• Anticipated Primary Completion Date: Mar 1, 2018
• Anticipated Study Completion Date: Sep 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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)	Procedure: Quantification of hepatic steatosis; Quantification of hepatic steatosis (histology, and in MRI)

Outcome Measures

Primary Outcome Measures

1. 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

1. Measurement of intrahepatic iron [at day 1]

2. Measurement of intrahepatic fibrosis [at day 1]

3. Measurement of fat in different hepatic segments [at day 1]

   (MRI )

4. Concordance between observers [at day 1]

   (for MRI measurements)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Clermont-Ferrand	Clermont-Ferrand		France	63003

Sponsors and Collaborators

• University Hospital, Clermont-Ferrand

Investigators

• Principal Investigator: Louis BOYER, University Hospital, Clermont-Ferrand

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Clermont-Ferrand
• ClinicalTrials.gov Identifier: NCT03142698
• Other Study ID Numbers: CHU-317; 2016-A02065-46
• First Posted: May 5, 2017
• Last Update Posted: May 5, 2017
• Last Verified: May 1, 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Clermont-Ferrand: hepatic steatosis; MRImaging
• Additional relevant MeSH terms: Fatty Liver

Study Results

No Results Posted as of May 5, 2017