Ultrasound Based Acoustic Radiation Force Impulse Imaging

ARFI (Ultrasound-based Acoustic Radiation Force Impulse) will be used during ultrasound guided needle biopsy of the liver of children.

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Key information

Conditions

Liver Fibrosis Digestive System Diseases Fibrosis Hepatitis Liver Cirrhosis Liver Diseases Liver Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

About this study

A new technique based on ultrasound, known as Acoustic Radiation Force Impulse (ARFI) imaging is performed using standard approved ultrasound machines and transducers. The sound waves or impulses are generated in a different pattern and offer information on the stiffness of the tissue. This new technique will be evaluated for usefulness in diagnosing different liver conditions.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

18 years of age or younger
Scheduled to have a needle biopsy of the liver at

C.S. Mott Children's Hospital or
Dept. of Radiology at the Univ. of Michigan Hospital
Scheduled to have an abdominal ultrasound to evaluate your liver (with no known liver disease)

Exclusion criteria

None to list

Treatment and study plan

Ultrasound-Based Acoustic Radiation Force Impulse (ARFI)

Device

Research scans using ultrasound-based acoustic radiation force impulse (ARFI) will image the liver non-invasively.

Primary outcomes

ARFI/VTQ and ARFI/VTIQ Liver Shear Wave Speed vs. Liver Histologic Fibrosis Score

Time frame: 10 minutes

Tissue shear wave speed is positively correlated to a material's/tissue's stiffness and can be noninvasively measured by ultrasound. The relationship between liver shear wave speed and liver histologic fibrosis score were assessed using 2 different ultrasound methods. Liver shear wave speed as obtained using 2 different ultrasound methods served as our primary outcome measures.

Note, the histologic scoring system (Ishak) ranged from 0 to 6, where 0 = no fibrosis and 6 = cirrhosis.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

Ultrasound Based Acoustic Radiation Force Impulse, Shear Wave Velocity Imaging in Pediatric Patients Undergoing Liver Biopsy

Important dates

Study start: 2012
Primary completion: 2015
Study completion: 2015
First posted: Jan 31, 2013
Registry last updated: Oct 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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