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

Cincinnati Children's Hospital Medical Center logo

Cincinnati Children's Hospital Medical Center

Status

Completed

Conditions

Chronic Liver Disease

Treatments

Device: Acoustic Radiation Force Imaging

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02652221
2014-0478

Details and patient eligibility

About

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.

Full 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.

Enrollment

55 patients

Sex

All

Ages

1 day to 25 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

55 participants in 1 patient group

Study cohort
Experimental group
Description:
Acoustic Radiation Force Imaging
Treatment:
Device: Acoustic Radiation Force Imaging

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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