Using the Non Invasive Technology Magnetic Resonance Elastography for the Diagnosis of Liver Fibrosis Stage
Study Details
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 |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: 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
|
| Other: 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
- Liver Biopsy Result for liver fibrosis grade [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.
- Magnetic Resonance Elastography (MRE) Result for liver fibrosis grade [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
- Shear Wave Elastography Result for liver fibrosis grade [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
Criteria
Inclusion Criteria:
- Patients with chronic liver diseases
Exclusion Criteria:
- Patients who don't have chronic liver diseases
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sheba Medical Center | Ramat Gan | Israel | 5265601 |
Sponsors and Collaborators
- Prof. Ziv Ben-Ari MD
Investigators
- Principal Investigator: Ziv Ben-Ari, MD, Liver Diseases Center, Sheba M.C
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SHEBA-17-4749-ZBA-CTIL