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

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ClinicalTrials.gov Identifier: NCT03382119
Recruitment Status : Recruiting
First Posted : December 22, 2017
Last Update Posted : March 13, 2019
Sponsor:
Collaborator:
Children's Hospital Medical Center, Cincinnati
Information provided by (Responsible Party):
Frank DiPaola, University of Michigan

Brief 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.


Condition or disease Intervention/treatment Phase
Liver Fibroses Device: Ultrasound with ARFI (acoustic radiation force impulse) Device: Ultrasound with backscatter imaging Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects from two patient populations will be enrolled in order to test these two technologies.
Masking: Single (Outcomes Assessor)
Masking Description: data analysts will be blinded to the subject's cohort assignment
Primary Purpose: Diagnostic
Official Title: Increased Liver Stiffness: A Study of Acoustic Radiation Force Impulse (ARFI) Elastography
Actual Study Start Date : April 11, 2018
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patients having Fontan cardiac surgery

This group includes pediatric patients, aged 2-5 years, who have had a Fontan operation. This surgery corrects a heart defect found at birth in which the heart has only one ventricle.

Patients will have an Ultrasound with ARFI imaging.

Device: Ultrasound with ARFI (acoustic radiation force impulse)
This technology uses sound waves to measure the stiffness of tissue.
Other Name: elastography

Device: Ultrasound with backscatter imaging
This ultrasound tool gathers data from the waves returning from imaged tissue.

Experimental: Patients with Liver disease

This group includes pediatric patients, aged 2-5 years, who have chronic liver disease caused by biliary atresia.

Patients will have an Ultrasound with ARFI imaging.

Device: Ultrasound with ARFI (acoustic radiation force impulse)
This technology uses sound waves to measure the stiffness of tissue.
Other Name: elastography

Device: Ultrasound with backscatter imaging
This ultrasound tool gathers data from the waves returning from imaged tissue.




Primary Outcome Measures :
  1. Change in liver shear wave speed as assessed by ARFI elastography [ Time Frame: Time 0 = before Fontan operation, and Time 1 = 1 week after Fontan operation ]
    Shear wave speed is a measure of stiffness of liver tissue expressed in units of m/s



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03382119


Contacts
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Contact: Frank DiPaola, MD 734-763-9650 dipaolaf@umich.edu
Contact: Jim Pool, BS 734 6157391 jampool@umich.edu

Locations
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United States, Michigan
C.S. Mott Hospital Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Frank DiPaola, MD         
Sponsors and Collaborators
University of Michigan
Children's Hospital Medical Center, Cincinnati
Investigators
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Principal Investigator: Frank DiPaola, MD University of Michigan

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Responsible Party: Frank DiPaola, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03382119     History of Changes
Other Study ID Numbers: HUM 130099
First Posted: December 22, 2017    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Frank DiPaola, University of Michigan:
liver stiffness Fontan

Additional relevant MeSH terms:
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Liver Cirrhosis
Liver Diseases
Digestive System Diseases