NCT03382119

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 25 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 2 Years – 5 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

If patients have liver congestion, reversing it could prevent liver fibrosis, which cannot be treated. Liver fibrosis has serious health risks and is associated with a higher chance of developing liver cancer later in life. Subjects from two patient populations will be enrolled in order to test ultrasound technologies. A total of 30 subjects between 2-5 years of age will be enrolled. 1. 15 children with increased liver stiffness due to the Fontan operation 2. 15 children with increased liver stiffness caused by Biliary Atresia.

Conditions

• Liver Fibroses

Interventions

Type	Name	Description
DEVICE	Ultrasound with ARFI (acoustic radiation force impulse)	This technology uses sound waves to measure the stiffness of tissue.
DEVICE	Ultrasound with backscatter imaging	This ultrasound tool gathers data from the waves returning from imaged tissue.

Timeline

• Start date: 2018-04-11
• Primary completion: 2019-07-19
• Completion: 2019-07-19
• First posted: 2017-12-22
• Last updated: 2020-06-02

Locations

1 site across 1 country: United States