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

Liver Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03487159
• Other study ID #: SHEBA-17-4749-ZBA-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: February 19, 2018
• Last updated: April 2, 2018
• Start date: May 1, 2018
• Est. completion date: June 1, 2019

Study information

• Verified date: April 2018
• Source: Sheba Medical Center
• Contact: Avishag Hassid
• Phone: +972-35307176
• Email: avishag.hassid[@]sheba.health.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: June 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Patients with chronic liver diseases

Exclusion Criteria:

• Patients who don't have chronic liver diseases

Related Conditions & MeSH terms

• Liver Cirrhosis
• Liver Diseases

Intervention

Device:
• MRE (Magnetic Resonance Elastography)
The device is using to evaluate liver fibrosis stage

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Ziv Ben-Ari MD

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.