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

Liver Fibrosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01781208
• Other study ID #: HUM00063736
• Status: Completed
• Phase: N/A
• First received: January 29, 2013
• Last updated: May 29, 2015
• Start date: November 2012
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

A new technique called Ultrasound-based Acoustic Radiation Force Impulse (ARFI)imaging is performed using standard approved ultrasound machines and transducers but the sound waves or impulses are produced in a different pattern. We are going to evaluate the usefulness of this new technique in diagnosing different liver conditions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Hepatitis
• Inflammation
• Liver Fibrosis
• Liver Inflammation

Intervention

Device:
• Ultrasound-Based Acoustic Radiation Force Impulse (ARFI)
Research scan using an ultrasound-based acoustic radiation force impulse will be used to image the liver. This is non-invasive and will take approximately 5 to 10 minutes to complete.

Locations

Country	Name	City	State
United States	University of Michigan Hospital	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acoustic Radiation Force Impulse Imaging	To confirm that the sound waves and or impulses produced by this new ultrasound-based imaging effectively aids in the diagnosis of different liver conditions such as fibrosis and inflammation and/or rejection.	6 months	Yes