Ultrasound Based Acoustic Radiation Force Impulse, Shear Wave Velocity Imaging in Pediatric Patients Undergoing Liver Biopsy
This study is currently recruiting participants.
Verified January 2013 by University of Michigan
Sponsor:
University of Michigan
Information provided by (Responsible Party):
Jonathan R. Dillman M.D., University of Michigan
ClinicalTrials.gov Identifier:
NCT01781208
First received: January 29, 2013
Last updated: January 31, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Liver Fibrosis Liver Inflammation |
Device: Ultrasound-Based Acoustic Radiation Force Impulse (ARFI) |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
Resource links provided by NLM:
Genetics Home Reference related topics:
North American Indian childhood cirrhosis
U.S. FDA Resources
Further study details as provided by University of Michigan:
Primary Outcome Measures:
- Acoustic Radiation Force Impulse Imaging [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]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.
| Estimated Enrollment: | 300 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | January 2016 |
| Estimated Primary Completion Date: | November 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Ultrasound-based Acoustic Radiation Force Impulse (ARFI)
Research scans using the ultrasound-based acoustic radiation force impulse imaging technique will be completed. This research imaging will take approximately 5 to 10 minutes to complete.
|
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.
|
Eligibility| Ages Eligible for Study: | up to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01781208
Contacts
| Contact: Jonathan Dillman, M.D. | 734-232-9247 | |
| Contact: James Pool, Jr., CCRC | 734-615-7391 | jampool@umich.edu |
Locations
| United States, Michigan | |
| University of Michigan Hospital | Recruiting |
| Ann Arbor, Michigan, United States, 48109 | |
| Contact: Jonathan Dillman, M.D. 734-232-9247 | |
| Contact: James Pool Jr., CCRC 734-615-7391 jampool@umich.edu | |
| Principal Investigator: Jonathan Dillman, M.D. | |
Sponsors and Collaborators
University of Michigan
Investigators
| Principal Investigator: | Jonathan Dillman, M.D. | University of Michigan Hospital |
More Information
No publications provided
| Responsible Party: | Jonathan R. Dillman M.D., Principal Investigator, University of Michigan |
| ClinicalTrials.gov Identifier: | NCT01781208 History of Changes |
| Other Study ID Numbers: | HUM00063736 |
| Study First Received: | January 29, 2013 |
| Last Updated: | January 31, 2013 |
| Health Authority: | United States: Institutional Review Board United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Fibrosis Inflammation Liver Cirrhosis |
Pathologic Processes Liver Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013