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

Not Applicable

Completed

• Conditions: Chronic Liver Disease
• Interventions: Device: Acoustic Radiation Force Imaging

• Registration Number: NCT02652221
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-06
• Primary Completion: 2015-12
• Study First Submitted: 2016-01-04
• Study First Submitted QC: 2016-01-08
• Study First Posted: 2016-01-11
• Study Completion: 2016-05
• Results First Submitted: 2017-01-31
• Status Verified: 2017-06
• Results First Submitted QC: 2017-06-13
• Last Update Submitted: 2017-06-13
• Results First Posted: 2017-07-12
• Last Update Posted: 2017-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study cohort	Acoustic Radiation Force Imaging	Acoustic Radiation Force Imaging

Primary Outcome Measures

Name	Time	Method
Agreement in Measured Liver Stiffness Between ARFI and MRE	Within 24 hours	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