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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Liver Diseases

Intervention / Treatment
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* Device: MRE (Magnetic Resonance Elastography)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with chronic liver diseases Exclusion Criteria: Patients who don't have chronic liver diseases

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study model includes 2 study arms: 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. 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Liver biopsy ,Elastography and MRE<br>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)<br>* The device is using to evaluate liver fibrosis stage<br>|
| Other: Elastography and MRE<br>Performance of routine Shear Wave Elastography and investigational MRE (Magnetic Resonance Elastography) in order to evaluate liver fibrosis stage. | Device: MRE (Magnetic Resonance Elastography)<br>* The device is using to evaluate liver fibrosis stage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |