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Ultrasound Based Acoustic Radiation Force Impulse Imaging

Primary Purpose

Liver Fibrosis, Liver Inflammation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultrasound-Based Acoustic Radiation Force Impulse (ARFI)
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Liver Fibrosis

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Michigan Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ultrasound-based Acoustic Radiation Force Imaging

Arm Description

The liver was scanned using ultrasound and ultrasound-based acoustic radiation force impulse imaging technique (ARFI).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 29, 2013
Last Updated
August 29, 2016
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT01781208
Brief Title
Ultrasound Based Acoustic Radiation Force Impulse Imaging
Official Title
Ultrasound Based Acoustic Radiation Force Impulse, Shear Wave Velocity Imaging in Pediatric Patients Undergoing Liver Biopsy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Fibrosis, Liver Inflammation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound-based Acoustic Radiation Force Imaging
Arm Type
Experimental
Arm Description
The liver was scanned using ultrasound and ultrasound-based acoustic radiation force impulse imaging technique (ARFI).
Intervention Type
Device
Intervention Name(s)
Ultrasound-Based Acoustic Radiation Force Impulse (ARFI)
Intervention Description
Research scans using ultrasound-based acoustic radiation force impulse (ARFI) will image the liver non-invasively.
Primary Outcome Measure Information:
Title
ARFI/VTQ and ARFI/VTIQ Liver Shear Wave Speed vs. Liver Histologic Fibrosis Score
Description
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.
Time Frame
10 minutes

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Dillman, M.D.
Organizational Affiliation
University of Michigan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Ultrasound Based Acoustic Radiation Force Impulse Imaging

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