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

• ClinicalTrials.gov Identifier: NCT03487159
• Recruitment Status: Unknown
• First Posted: April 3, 2018
• Last Update Posted: April 3, 2018
• Sponsor: Prof. Ziv Ben-Ari MD
• Information provided by (Responsible Party): Prof. Ziv Ben-Ari MD, Sheba Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Liver Diseases	Device: MRE (Magnetic Resonance Elastography)	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 140 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment

Intervention Model Description

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.

• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Using the Non Invasive Technology Magnetic Resonance Elastography for the Diagnosis of Liver Fibrosis Stage
• Estimated Study Start Date: May 1, 2018
• Estimated Primary Completion Date: May 1, 2019
• Estimated Study Completion Date: June 1, 2019

Arms and Interventions

Arm	Intervention/treatment
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.	Device: MRE (Magnetic Resonance Elastography); 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.	Device: MRE (Magnetic Resonance Elastography); The device is using to evaluate liver fibrosis stage

Outcome Measures

Primary Outcome Measures :

1. Liver Biopsy Result for liver fibrosis grade [ Time Frame: Patient will undergo Liver biopsy once during 1 year of the study. ]

   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.

2. Magnetic Resonance Elastography (MRE) Result for liver fibrosis grade [ Time Frame: Patient will undergo Magnetic Resonance Elastography (MRE) once during 1 year of the study. ]
   Liver Fibrosis score determined by liver stiffness in 4 fibrosis grades: >1=any fibrosis, >2=significant fibrosis, >3=advanced fibrosis, 4=cirrhosis
3. Shear Wave Elastography Result for liver fibrosis grade [ Time Frame: Patient will undergo Shear Wave Elastography once during 1 year of the study. ]
   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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 100 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Patients with chronic liver diseases

Exclusion Criteria:

• Patients who don't have chronic liver diseases

Contacts and Locations

Contacts

Contact: Avishag Hassid; +972-35307176; avishag.hassid@sheba.health.gov.il

Locations

Israel

Sheba Medical Center

Ramat Gan, Israel, 5265601

Contact: Ziv Ben-Ari, MD 972-3-5307180

Contact: Avishag Hassid 972-3-5307176 avishag.hassid@sheba.health.gov.il

Principal Investigator: Ziv Ben-Ari, MD

Sponsors and Collaborators

Prof. Ziv Ben-Ari MD

Investigators

• Principal Investigator: Ziv Ben-Ari, MD; Liver Diseases Center, Sheba M.C

More Information

• Responsible Party: Prof. Ziv Ben-Ari MD, Head of Liver Diseases Center, Sheba Medical Center
• ClinicalTrials.gov Identifier: NCT03487159
• Other Study ID Numbers: SHEBA-17-4749-ZBA-CTIL
• First Posted: April 3, 2018
• Last Update Posted: April 3, 2018
• Last Verified: April 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Liver Diseases; Liver Cirrhosis; Fibrosis; Pathologic Processes; Digestive System Diseases