Quantification of Hepatic Fibrosis by IVIM Sequences in 1.5T MRI

NCT ID: NCT03173287

Last Updated: 2017-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2018-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Liver Fibrosis MRI IVIM Liver Biopsy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Open

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Quantification of liver fibrosis

Intervention Type PROCEDURE

Procedure MRI and liver biopsy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Quantification of liver fibrosis

Procedure MRI and liver biopsy

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Benoit MAGNIN

Role: PRINCIPAL_INVESTIGATOR

CHU de Clermont-Ferrand

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU de Clermont-Ferrand

Clermont-Ferrand, Auvergne, France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Patrick LACARIN

Role: CONTACT

04 73 75 11 95

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Patrick LACARIN

Role: primary

04 73 75 11 95

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2016-A02066-45

Identifier Type: OTHER

Identifier Source: secondary_id

CHU-327

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Methods to Detect Liver Fibrosis
NCT03027700 TERMINATED NA
68Ga-FAPI PET/CT in Liver Fibrosis Patients
NCT04533828 UNKNOWN EARLY_PHASE1
MRI in Portal Hypertension
NCT01756859 UNKNOWN