Ultrasound Based Acoustic Radiation Force Impulse Imaging

Not Applicable

Completed

• Conditions: Liver Fibrosis; Liver Inflammation
• Interventions: Device: Ultrasound-Based Acoustic Radiation Force Impulse (ARFI)

• Registration Number: NCT01781208
• Lead Sponsor: University of Michigan

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-01-29
• Study First Submitted QC: 2013-01-29
• Study First Posted: 2013-01-31
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Results First Submitted: 2016-04-26
• Status Verified: 2016-08
• Results First Submitted QC: 2016-08-29
• Last Update Submitted: 2016-08-29
• Results First Posted: 2016-10-21
• Last Update Posted: 2016-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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)

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Exclusion Criteria

• None to list

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ultrasound-based Acoustic Radiation Force Imaging	Ultrasound-Based Acoustic Radiation Force Impulse (ARFI)	The liver was scanned using ultrasound and ultrasound-based acoustic radiation force impulse imaging technique (ARFI).

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Michigan Hospital; 🇺🇸 Ann Arbor, Michigan, United States