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Quantification of Hepatic Fibrosis by IVIM Sequences in 1.5T MRI (IVIM-MRI)

Primary Purpose

Liver Fibrosis, MRI, IVIM

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

About this trial

This is an interventional diagnostic trial for Liver Fibrosis focused on measuring Hepatic fibrosis, IVIM, 1.5T MRI

Eligibility Criteria

18 Years - 100 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 de Clermont-FerrandRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with hepatic biopsy

Arm Description

The patients having benefited from a hepatic biopsy for evaluation of the hepatic fibrosis, will benefit in 10 days of a MRI in the service of radiology of the hospital Gabriel Montpied.

Outcomes

Primary Outcome Measures

Measured perfusion-related scattering value
The main objective of this study is to show that the measured perfusion-related scattering value (D *) is related to the hepatic fibrosis stage.

Secondary Outcome Measures

Measured perfusion-related of infusion fraction
Measured perfusion-related of molecular diffusion
Measured perfusion-related of ADC

Full Information

First Posted
May 9, 2017
Last Updated
May 31, 2017
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT03173287
Brief Title
Quantification of Hepatic Fibrosis by IVIM Sequences in 1.5T MRI
Acronym
IVIM-MRI
Official Title
Quantification of Hepatic Fibrosis by IVIM Sequences in 1.5T MRI.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
March 1, 2017 (Actual)
Study Completion Date
November 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
Quantification of hepatic fibrosis by IVIM sequences in 1.5T MRI.
Detailed Description
Early and accurate diagnosis of hepatic fibrosis in patients with chronic liver disease is essential and essential. This assessment could be performed by a non-invasive MRI method. The main objective of this study is to show that the measured perfusion-related scattering value (D *) is related to the hepatic fibrosis stage. Secondary objectives Evaluation of infusion fraction (f) and fibrosis stage. Evaluation of molecular diffusion (D) and fibrosis stage. Evaluation of ADC and fibrosis stage. Assess whether there is a link between the etiology of fibrosis and the value of the diffusion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Fibrosis, MRI, IVIM, Liver Biopsy
Keywords
Hepatic fibrosis, IVIM, 1.5T MRI

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Patients with hepatic biopsy
Arm Type
Experimental
Arm Description
The patients having benefited from a hepatic biopsy for evaluation of the hepatic fibrosis, will benefit in 10 days of a MRI in the service of radiology of the hospital Gabriel Montpied.
Intervention Type
Procedure
Intervention Name(s)
Quantification of liver fibrosis
Intervention Description
Procedure MRI and liver biopsy
Primary Outcome Measure Information:
Title
Measured perfusion-related scattering value
Description
The main objective of this study is to show that the measured perfusion-related scattering value (D *) is related to the hepatic fibrosis stage.
Time Frame
at day 1
Secondary Outcome Measure Information:
Title
Measured perfusion-related of infusion fraction
Time Frame
at day 1
Title
Measured perfusion-related of molecular diffusion
Time Frame
at day 1
Title
Measured perfusion-related of ADC
Time Frame
at day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 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-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benoit MAGNIN
Organizational Affiliation
CHU de Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
State/Province
Auvergne
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
Benoit MAGNIN

12. IPD Sharing Statement

Learn more about this trial

Quantification of Hepatic Fibrosis by IVIM Sequences in 1.5T MRI

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