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

NCT ID: NCT03487159

Last Updated: 2018-04-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2019-06-01

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.

Detailed Description

Recent advances in magnetic resonance imaging (MRI) of the liver have led to improvements in diagnosis of chronic liver diseases. Detection and staging of liver fibrosis has become important; however, until about the last decade, it depended on an invasive liver biopsy. Liver biopsy is limited by high cost, low patient acceptance, interobserver variability during microscopic evaluation, sampling error, poor reproducibility, and, importantly, an invasive nature with a complication rate of 3% and a mortality rate of 0.03%. With the emergence of elastography techniques, the need for liver biopsy has rapidly diminished for diagnosis of clinically significant liver fibrosis. Magnetic Resonance Elastography has gained increasing popularity in recent years, in large part due to its higher technical success and ability to overcome some of the weaknesses of ultrasound-based methods for assessing liver fibrosis.

Conditions

Liver Diseases

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Liver biopsy ,Elastography and MRE

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

Group Type: OTHER

MRE (Magnetic Resonance Elastography)

Intervention Type: DEVICE

The device is using to evaluate liver fibrosis stage

Elastography and MRE

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

Group Type: OTHER

MRE (Magnetic Resonance Elastography)

Intervention Type: DEVICE

The device is using to evaluate liver fibrosis stage

Interventions

MRE (Magnetic Resonance Elastography)

The device is using to evaluate liver fibrosis stage

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients with chronic liver diseases

Exclusion Criteria

• Patients who don't have chronic liver diseases

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prof. Ziv Ben-Ari MD

OTHER_GOV

Sponsor Role: lead

Responsible Party

Prof. Ziv Ben-Ari MD

Head of Liver Diseases Center

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ziv Ben-Ari, MD

Role: PRINCIPAL_INVESTIGATOR

Liver Diseases Center, Sheba M.C

Locations

Sheba Medical Center

Ramat Gan, , Israel

Countries

Israel

Central Contacts

Avishag Hassid

Role: CONTACT

avishag.hassid@sheba.health.gov.il

+972-35307176

Facility Contacts

Ziv Ben-Ari, MD

Role: primary

972-3-5307180

Avishag Hassid

Role: backup

avishag.hassid@sheba.health.gov.il

972-3-5307176

Other Identifiers

SHEBA-17-4749-ZBA-CTIL

Identifier Type: -

Identifier Source: org_study_id