Increased Liver Stiffness: A Study of Acoustic Radiation Force Impulse (ARFI) Elastography

Completed

Conditions studied: Liver Fibroses

In brief

The goal of this study is to determine if ultrasound tools can be used to detect liver stiffness. Acoustic radiation force impulse (ARFI) elastography and backscatter will be used to see if they can detect liver stiffness in different populations of patients with liver disease. The study is measuring liver stiffness in pediatric patients aged 2-5 years. Patients either have had a Fontan cardiac surgery or have liver disease. Ultrasound scanning takes images of the liver and has much lower risks for patients. ARFI elastography and other tools can be used to measure liver stiffness.

Key facts

Study ID

NCT03382119

Run by

University of Michigan

People needed

25

Starts

2018-04-11

Expected to finish

2019-07-19

Last updated by the study team

2020-06-02

Who can join

Age: 2 and older, up to 5. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients aged 2-5 years
• Children who are scheduled to have a Stage 3 Fontan cardiac operation (arm 1) AND Children who have chronic liver disease caused by biliary atresia (arm 2)
• Patient must be receiving care at the University of Michigan CS Mott Children's Hospital
• Parent/guardian must be willing to sign the study consent form

You may not qualify if…

• For arm 1 subjects: pre-existing evidence of chronic liver disease (as defined by chronic elevation (over 4 weeks) of alanine aminotransferase (ALT), aspartate aminotransferase (AST), or conjugated bilirubin to greater than two times the upper limit of normal
• For arm 1 subjects: evidence of overt liver nodularity by conventional US imaging or evidence of portal vein or hepatic vein thrombosis (clots) by US Doppler exam

Where it is running

• C.S. Mott Hospital — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.