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

Quantification of Hepatic Fibrosis by IVIM Sequences in 1.5T MRI.

Quantification of hepatic fibrosis by IVIM sequences in 1.5T MRI.

Study Overview

• Status: Unknown
• Conditions: MRI; Liver Fibrosis; Liver Biopsy; IVIM
• Intervention / Treatment: Procedure: Quantification of liver fibrosis

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.

• Study Type: Interventional
• Enrollment (Anticipated): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Auvergne
    • Clermont-Ferrand, Auvergne, France, 63003
      • Recruiting
      • CHU de Clermont-Ferrand
      • Principal Investigator: Benoit MAGNIN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 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

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with hepatic biopsy; 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.	Procedure: Quantification of liver fibrosis; Procedure MRI and liver biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at day 1

Secondary Outcome Measures

Outcome Measure	Time Frame
Measured perfusion-related of infusion fraction	at day 1
Measured perfusion-related of molecular diffusion	at day 1
Measured perfusion-related of ADC	at day 1

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Benoit MAGNIN, CHU de Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): March 1, 2017
• Study Completion (Anticipated): November 1, 2018

Study Registration Dates

• First Submitted: May 9, 2017
• First Submitted That Met QC Criteria: May 31, 2017
• First Posted (Actual): June 1, 2017

Study Record Updates

• Last Update Posted (Actual): June 1, 2017
• Last Update Submitted That Met QC Criteria: May 31, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Hepatic fibrosis; IVIM; 1.5T MRI
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: CHU-327; 2016-A02066-45 (Other Identifier: 2016-A02066-45)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No