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

Chronic Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02652221
• Other study ID #: 2014-0478
• Status: Completed
• Phase: N/A
• First received: January 4, 2016
• Last updated: July 28, 2016
• Start date: June 2014
• Est. completion date: May 2016

Study information

• Verified date: July 2016
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: May 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 25 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Chronic Liver Disease
• Liver Diseases

Intervention

Device:
• Acoustic Radiation Force Imaging
ARFI US is a novel technique, recently FDA approved for use in children and adults, which provides an alternative method for quantifying liver stiffness.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	Siemens Medical Solutions

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Agreement in measured shearwave speed 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	No