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

P

Prof. Ziv Ben-Ari MD

Status

Unknown

Conditions

Liver Diseases

Treatments

Device: MRE (Magnetic Resonance Elastography)

Study type

Interventional

Funder types

Other

Identifiers

NCT03487159
SHEBA-17-4749-ZBA-CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment

140 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with chronic liver diseases

Exclusion criteria

  • Patients who don't have chronic liver diseases

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

140 participants in 2 patient groups

Liver biopsy ,Elastography and MRE
Other group
Description:
Performance of routine Liver biopsy,Shear Wave Elastography and investigational MRE (Magnetic Resonance Elastography) in order to evaluate liver fibrosis stage.
Treatment:
Device: MRE (Magnetic Resonance Elastography)
Elastography and MRE
Other group
Description:
Performance of routine Shear Wave Elastography and investigational MRE (Magnetic Resonance Elastography) in order to evaluate liver fibrosis stage.
Treatment:
Device: MRE (Magnetic Resonance Elastography)

Trial contacts and locations

1

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Central trial contact

Avishag Hassid

Data sourced from clinicaltrials.gov

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