Ultrasound Based Acoustic Radiation Force Impulse Imaging

August 29, 2016 updated by: Jonathan R. Dillman M.D., University of Michigan

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years of age or younger

  • Scheduled to have a needle biopsy of the liver at

    1. C.S. Mott Children's Hospital or
    2. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultrasound-based Acoustic Radiation Force Imaging
The liver was scanned using ultrasound and ultrasound-based acoustic radiation force impulse imaging technique (ARFI).
Device: Ultrasound-Based Acoustic Radiation Force Impulse (ARFI)
Research scans using ultrasound-based acoustic radiation force impulse (ARFI) will image the liver non-invasively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

January 29, 2013

First Submitted That Met QC Criteria

January 29, 2013

First Posted (Estimate)

January 31, 2013

Study Record Updates

Last Update Posted (Estimate)

October 21, 2016

Last Update Submitted That Met QC Criteria

August 29, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00063736

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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