Determination of Liver Stiffness in Chronic Liver Disease Patients by Acoustic Radiation Force Imaging (ARFI) Ultrasound

Study Overview
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Brief Summary
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A prospective, pilot study using acoustic radiation force imaging (ARFI) ultrasound (US) to quantify liver stiffness in children and young adults with chronic liver disease. ARFI results will be compared to the current clinical standard of Magnetic Resonance Elastography (MRE) and to liver biopsy when available.

Detailed Description
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ARFI US is a novel technique, recently FDA approved for use in children and adults, which provides an alternative method for quantifying liver stiffness. ARFI US has been shown in a small pilot investigation in Europe in children to be reliable and rapid in estimating moderate to severe liver stiffness using histology as a reference gold standard. ARFI measures the speed of a shear wave in the examined tissue, expressed in m/s. This shear wave velocity can be mathematically converted into a liver stiffness value, which can then be used to estimate degree of liver fibrosis. The technique is non-invasive, uses no ionizing radiation, and is fast (several minutes to complete). It is possible that ARFI US will be more accurate than MRE in quantifying liver stiffness. In addition, ARFI US will ultimately be a less expensive clinical test, shorter in duration, and will not require sedation/anesthesia in younger children as MRE requires.

Official Title
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Determination of Liver Stiffness in Chronic Liver Disease Patients by Acoustic Radiation Force Imaging (ARFI) Ultrasound

Conditions
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Chronic Liver Disease

Intervention / Treatment
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* Device: Acoustic Radiation Force Imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Less than 25 years old with chronic liver disease Exclusion Criteria: Subjects without clinically ordered MRE Subjects who cannot cooperate with performance of the short ARFI exam

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 25 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study cohort<br>Acoustic Radiation Force Imaging | Device: Acoustic Radiation Force Imaging<br>* ARFI US is a novel technique, recently FDA approved for use in children and adults, which provides an alternative method for quantifying liver stiffness.<br>* Other names: ARFI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Agreement in Measured Liver Stiffness Between ARFI and MRE | The investigators are seeking to define agreement between ARFI and MRE liver stiffness measurements obtained in the same patients on the same day to determine if the modalities can be used interchangeably for measurement of liver stiffness and prediction of significant liver fibrosis | Within 24 hours |