Using the Non Invasive Technology Magnetic Resonance Elastography for the Diagnosis of Liver Fibrosis Stage
Primary Purpose
Liver Diseases
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
MRE (Magnetic Resonance Elastography)
Sponsored by
About this trial
This is an interventional diagnostic trial for Liver Diseases
Eligibility Criteria
Inclusion Criteria:
- Patients with chronic liver diseases
Exclusion Criteria:
- Patients who don't have chronic liver diseases
Sites / Locations
- Sheba Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Liver biopsy ,Elastography and MRE
Elastography and MRE
Arm Description
Performance of routine Liver biopsy,Shear Wave Elastography and investigational MRE (Magnetic Resonance Elastography) in order to evaluate liver fibrosis stage.
Performance of routine Shear Wave Elastography and investigational MRE (Magnetic Resonance Elastography) in order to evaluate liver fibrosis stage.
Outcomes
Primary Outcome Measures
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.
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
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03487159
Brief Title
Using the Non Invasive Technology Magnetic Resonance Elastography for the Diagnosis of Liver Fibrosis Stage
Official Title
Using the Non Invasive Technology Magnetic Resonance Elastography for the Diagnosis of Liver Fibrosis Stage
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2018 (Anticipated)
Primary Completion Date
May 1, 2019 (Anticipated)
Study Completion Date
June 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prof. Ziv Ben-Ari MD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Diseases
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Liver biopsy ,Elastography and MRE
Arm Type
Other
Arm Description
Performance of routine Liver biopsy,Shear Wave Elastography and investigational MRE (Magnetic Resonance Elastography) in order to evaluate liver fibrosis stage.
Arm Title
Elastography and MRE
Arm Type
Other
Arm Description
Performance of routine Shear Wave Elastography and investigational MRE (Magnetic Resonance Elastography) in order to evaluate liver fibrosis stage.
Intervention Type
Device
Intervention Name(s)
MRE (Magnetic Resonance Elastography)
Intervention Description
The device is using to evaluate liver fibrosis stage
Primary Outcome Measure Information:
Title
Liver Biopsy Result for liver fibrosis grade
Description
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.
Time Frame
Patient will undergo Liver biopsy once during 1 year of the study.
Title
Magnetic Resonance Elastography (MRE) Result for liver fibrosis grade
Description
Liver Fibrosis score determined by liver stiffness in 4 fibrosis grades: >1=any fibrosis, >2=significant fibrosis, >3=advanced fibrosis, 4=cirrhosis
Time Frame
Patient will undergo Magnetic Resonance Elastography (MRE) once during 1 year of the study.
Title
Shear Wave Elastography Result for liver fibrosis grade
Description
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
Time Frame
Patient will undergo Shear Wave Elastography once during 1 year of the study.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with chronic liver diseases
Exclusion Criteria:
Patients who don't have chronic liver diseases
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Avishag Hassid
Phone
+972-35307176
Email
avishag.hassid@sheba.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ziv Ben-Ari, MD
Organizational Affiliation
Liver Diseases Center, Sheba M.C
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
5265601
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ziv Ben-Ari, MD
Phone
972-3-5307180
First Name & Middle Initial & Last Name & Degree
Avishag Hassid
Phone
972-3-5307176
Email
avishag.hassid@sheba.health.gov.il
First Name & Middle Initial & Last Name & Degree
Ziv Ben-Ari, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Using the Non Invasive Technology Magnetic Resonance Elastography for the Diagnosis of Liver Fibrosis Stage
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