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)

May 4, 2017 updated by: University Hospital, Clermont-Ferrand
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • Recruiting
        • CHU Clermont-Ferrand
        • Principal Investigator:
          • Louis BOYER

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation coefficient - for each quantitative MRI variable studied - with the histological score of hepatic steatosis.
Time Frame: at day 1
Correlation coefficient - for each quantitative MRI variable studied - with the histological score of hepatic steatosis.
at day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of intrahepatic iron
Time Frame: at day 1
at day 1
Measurement of intrahepatic fibrosis
Time Frame: at day 1
at day 1
Measurement of fat in different hepatic segments
Time Frame: at day 1
(MRI )
at day 1
Concordance between observers
Time Frame: at day 1
(for MRI measurements)
at day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

May 1, 2017

Primary Completion (ANTICIPATED)

March 1, 2018

Study Completion (ANTICIPATED)

September 1, 2018

Study Registration Dates

First Submitted

April 13, 2017

First Submitted That Met QC Criteria

May 4, 2017

First Posted (ACTUAL)

May 5, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 5, 2017

Last Update Submitted That Met QC Criteria

May 4, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-317
  • 2016-A02065-46 (OTHER: 2016-A02065-46)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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