Using the Non Invasive Technology Magnetic Resonance Elastography for the Diagnosis of Liver Fibrosis Stage

NCT03487159 | Unknown

• 1 other identifier: SHEBA-17-4749-ZBA-CTIL
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the ability of Magnetic Resonance Elastography non invasive technology to identify the liver fibrosis stage in patients with chronic liver diseases compared to Shear Wave Elastography and/or Liver Biopsy.

Conditions

Liver Diseases

Outcome Measures

Primary Outcomes (3)

• Liver Biopsy Result for liver fibrosis grade

  Liver Fibrosis score measured by Metavir scale .The Metavir score grades the degree of fibrosis on a 5-point scale from 0 to 4. The activity, which is the amount of inflammation (specifically, the intensity of necro-inflammatory lesions), is graded on a 4-point scale from A0 to A3. Fibrosis score: F0 = no fibrosis F1 = portal fibrosis without septa F2 = portal fibrosis with few septa F3 = numerous septa without cirrhosis F4 = cirrhosis Activity score: A0 = no activity A1 = mild activity A2 = moderate activity A3 = severe activity Liver biopsy will be perfomed only according to physician recommendation.

  Patient will undergo Liver biopsy once during 1 year of the study.

• Magnetic Resonance Elastography (MRE) Result for liver fibrosis grade

  Liver Fibrosis score determined by liver stiffness in 4 fibrosis grades: \>1=any fibrosis, \>2=significant fibrosis, \>3=advanced fibrosis, 4=cirrhosis

  Patient will undergo Magnetic Resonance Elastography (MRE) once during 1 year of the study.

• Shear Wave Elastography Result for liver fibrosis grade

  Liver Fibrosis score determined by liver stiffness in in 5 fibrosis grades: 0=no fibrosis, \>1=any fibrosis, \>2=significant fibrosis, \>3=advanced fibrosis, 4=cirrhosis

  Patient will undergo Shear Wave Elastography once during 1 year of the study.

Study Arms (2)

Liver biopsy ,Elastography and MRE

OTHER

Performance of routine Liver biopsy,Shear Wave Elastography and investigational MRE (Magnetic Resonance Elastography) in order to evaluate liver fibrosis stage.

Device: MRE (Magnetic Resonance Elastography)

Elastography and MRE

OTHER

Performance of routine Shear Wave Elastography and investigational MRE (Magnetic Resonance Elastography) in order to evaluate liver fibrosis stage.

Device: MRE (Magnetic Resonance Elastography)

Interventions

MRE (Magnetic Resonance Elastography) DEVICE

The device is using to evaluate liver fibrosis stage

Elastography and MRE; Liver biopsy ,Elastography and MRE

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with chronic liver diseases

You may not qualify if:

• Patients who don't have chronic liver diseases

Sponsors & Collaborators

• Prof. Ziv Ben-Ari MD: lead

Study Sites (1)

Sheba Medical Center

Ramat Gan, 5265601, Israel

Location

MeSH Terms

Conditions

Liver Diseases

Interventions

Elasticity Imaging Techniques

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Ziv Ben-Ari, MD

  Liver Diseases Center, Sheba M.C

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Avishag Hassid

CONTACT

+972-35307176; avishag.hassid@sheba.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Liver Diseases Center

Model Details: The study model includes 2 study arms: 1. Patients with chronic liver diseases who will undergo a routine liver biopsy, Shear Wave elastography and the MRE in order to evaluate the liver fibrosis stage. 2. Patients with chronic liver diseases who will undergo a routine Shear Wave elastography and the MRE in order to evaluate the liver fibrosis stage. Demographic and clinical information will be collected from the patient's medical files.

Study Record Dates

• First Submitted: February 19, 2018
• First Posted: April 3, 2018
• Study Start: May 1, 2018
• Primary Completion: May 1, 2019
• Study Completion: June 1, 2019
• Last Updated: April 3, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)