Ultrasound Based Acoustic Radiation Force Impulse Imaging
1 other identifier
interventional
62
1 country
1
Brief Summary
ARFI (Ultrasound-based Acoustic Radiation Force Impulse) will be used during ultrasound guided needle biopsy of the liver of children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 29, 2013
CompletedFirst Posted
Study publicly available on registry
January 31, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedResults Posted
Study results publicly available
October 21, 2016
CompletedOctober 21, 2016
August 1, 2016
2.5 years
January 29, 2013
April 26, 2016
August 29, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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.
10 minutes
Study Arms (1)
Ultrasound-based Acoustic Radiation Force Imaging
EXPERIMENTALThe liver was scanned using ultrasound and ultrasound-based acoustic radiation force impulse imaging technique (ARFI).
Interventions
Research scans using ultrasound-based acoustic radiation force impulse (ARFI) will image the liver non-invasively.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- None to list
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Michigan Hospital
Ann Arbor, Michigan, 48109, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jonathan Dillman, MD
- Organization
- Cincinnati Children's Hospital Medical Center, Department of Radiology
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan Dillman, M.D.
University of Michigan Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 29, 2013
First Posted
January 31, 2013
Study Start
November 1, 2012
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
October 21, 2016
Results First Posted
October 21, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will not share