Quantification of Hepatic Fibrosis by IVIM Sequences in 1.5T MRI

Not Applicable

• Conditions: Liver Fibrosis; MRI; IVIM; Liver Biopsy
• Interventions: Procedure: Quantification of liver fibrosis

• Registration Number: NCT03173287
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

Study Timeline

• Study Start: 2017-03-01
• Primary Completion: 2017-03-01
• Status Verified: 2017-05
• Study First Submitted: 2017-05-09
• Study First Submitted QC: 2017-05-31
• Last Update Submitted: 2017-05-31
• Study First Posted: 2017-06-01
• Last Update Posted: 2017-06-01
• Study Completion: 2018-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 63

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with hepatic biopsy	Quantification of liver fibrosis	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.

Primary Outcome Measures

Name	Time	Method
Measured perfusion-related scattering value	at day 1	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

Name	Time	Method
Measured perfusion-related of infusion fraction	at day 1
Measured perfusion-related of ADC	at day 1
Measured perfusion-related of molecular diffusion	at day 1

Trial Locations

Locations (1)

CHU de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, Auvergne, France