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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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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