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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02652221
Other study ID # 2014-0478
Secondary ID
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


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
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