Quantification of Hepatic Fibrosis by IVIM Sequences in 1.5T MRI

Liver Fibrosis Clinical Trial

— IVIM-MRI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03173287
• Other study ID #: CHU-327
• Secondary ID: 2016-A02066-45
• Status: Recruiting
• Phase: N/A
• First received: May 9, 2017
• Last updated: May 31, 2017
• Start date: March 1, 2017
• Est. completion date: November 2018

Study information

• Verified date: May 2017
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 63
• Est. completion date: November 2018
• Est. primary completion date: March 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• IVIM
• Liver Biopsy
• Liver Cirrhosis
• Liver Fibrosis
• MRI

Intervention

Procedure:
• Quantification of liver fibrosis
Procedure MRI and liver biopsy

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand	Auvergne

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Measured perfusion-related of infusion fraction		at day 1
Secondary	Measured perfusion-related of molecular diffusion		at day 1
Secondary	Measured perfusion-related of ADC		at day 1