Liver FibrosesNCT03382119
Increased Liver Stiffness: A Study of Acoustic Radiation Force Impulse (ARFI) Elastography
An observational study of Liver Fibroses, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Liver Fibroses
- What is being tested?
- Ultrasound with ARFI (acoustic radiation force impulse) and Ultrasound with backscatter imaging
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2018to 19 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients will either be scheduled for a Stage 3 Fontan cardiac operation or have chronic liver disease caused by biliary atresia.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- 15 children with increased liver stiffness due to the Fontan operation
- 15 children with increased liver stiffness caused by Biliary Atresia.
- Conditions
- Liver Fibroses
- Being tested
- Ultrasound with ARFI (acoustic radiation force impulse), Ultrasound with backscatter imaging
- Keywords
- liver stiffness Fontan
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound with ARFI (acoustic radiation force impulse)Device
Also called elastography
This technology uses sound waves to measure the stiffness of tissue.
Ultrasound with backscatter imagingDevice
This ultrasound tool gathers data from the waves returning from imaged tissue.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Ultrasound with ARFI (acoustic radiation force impulse); Device: Ultrasound with backscatter imaging | |
| 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. Receives: Device: Ultrasound with ARFI (acoustic radiation force impulse); Device: Ultrasound with backscatter imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shear wave speed
Shear wave speed is a measure of stiffness of liver tissue expressed in units of m/s
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2017
- Study start11 Apr 2018
- Primary completion19 Jul 2019
- Study completion19 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver FibrosesStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Medical Center, Cincinnati
- Responsible party
- Principal investigator, Frank DiPaola, University of Michigan
- Investigators
- Frank DiPaola, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03382119
- Sponsor's protocol ID
- HUM 130099
- Status last verified
- May 2020
- First submitted
- 13 Dec 2017
- Last updated
- 2 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increased Liver Stiffness: A Study of Acoustic Radiation Force Impulse (ARFI) Elastography
- ClinicalTrials.gov ID
- NCT03382119
- Acronym / sponsor ID
- HUM 130099
- Conditions
- Liver Fibroses
- Keywords
- liver stiffness Fontan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Children's Hospital Medical Center, Cincinnati
- Study start
- 11 Apr 2018 (actual)
- Primary completion
- 19 Jul 2019 (actual)
- Study completion
- 19 Jul 2019 (actual)
- First posted
- 22 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 15 children with increased liver stiffness due to the Fontan operation
- 15 children with increased liver stiffness caused by Biliary Atresia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients having Fontan cardiac surgery | – | Device: Ultrasound with ARFI (acoustic radiation force impulse), Device: Ultrasound with backscatter imagingThis 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. |
| Patients with Liver disease | – | Device: Ultrasound with ARFI (acoustic radiation force impulse), Device: Ultrasound with backscatter imagingThis 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. |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients will either be scheduled for a Stage 3 Fontan cardiac operation or have chronic liver disease caused by biliary atresia.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound with ARFI (acoustic radiation force impulse)Also: elastographyThis technology uses sound waves to measure the stiffness of tissue. | Device | Patients having Fontan cardiac surgery, Patients with Liver disease |
| Ultrasound with backscatter imagingThis ultrasound tool gathers data from the waves returning from imaged tissue. | Device | Patients having Fontan cardiac surgery, Patients with Liver disease |
Primary outcome
Shear wave speed
Time frame: 15 minutes
Shear wave speed is a measure of stiffness of liver tissue expressed in units of m/s
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank DiPaola, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Fibroses, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shear wave speed (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2020.