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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)

Primary Purpose

Hepatic Steatosis, MRI, Liver Biopsy

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Quantification of hepatic steatosis
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hepatic Steatosis focused on measuring hepatic steatosis, MRImaging

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHU Clermont-FerrandRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hepatic steatosis

Arm 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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Measurement of intrahepatic iron
Measurement of intrahepatic fibrosis
Measurement of fat in different hepatic segments
(MRI )
Concordance between observers
(for MRI measurements)

Full Information

First Posted
April 13, 2017
Last Updated
May 4, 2017
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT03142698
Brief 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
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 2017 (Anticipated)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Steatosis, MRI, Liver Biopsy, Quantification
Keywords
hepatic steatosis, MRImaging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hepatic steatosis
Arm Type
Experimental
Arm 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)
Intervention Type
Procedure
Intervention Name(s)
Quantification of hepatic steatosis
Intervention Description
Quantification of hepatic steatosis (histology, and in MRI)
Primary Outcome Measure Information:
Title
Correlation coefficient - for each quantitative MRI variable studied - with the histological score of hepatic steatosis.
Description
Correlation coefficient - for each quantitative MRI variable studied - with the histological score of hepatic steatosis.
Time Frame
at day 1
Secondary Outcome Measure Information:
Title
Measurement of intrahepatic iron
Time Frame
at day 1
Title
Measurement of intrahepatic fibrosis
Time Frame
at day 1
Title
Measurement of fat in different hepatic segments
Description
(MRI )
Time Frame
at day 1
Title
Concordance between observers
Description
(for MRI measurements)
Time Frame
at day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrnd.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louis BOYER
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Louis BOYER

12. IPD Sharing Statement

Learn more about this trial

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

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