Liver FibrosisNCT01781208

Ultrasound Based Acoustic Radiation Force Impulse Imaging

A study testing Ultrasound-Based Acoustic Radiation Force Impulse (ARFI) in people with Liver Fibrosis and Liver Inflammation, run by University of Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

ARFI (Ultrasound-based Acoustic Radiation Force Impulse) will be used during ultrasound guided needle biopsy of the liver of children. Read more about this study

Who is it for?: Ages Up to 18 yearsHealthy volunteers can take part
Conditions the study is for: Liver Fibrosis, Liver Inflammation
What is being tested?: Ultrasound-Based Acoustic Radiation Force Impulse (ARFI)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 62 participants
Where: 1 siteUnited States
Study dates: Nov 2012to May 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 Up to 18 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

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)

Who cannot join

None to list

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Michigan Hospital
Ann Arbor, Michigan, 48109

Other trials in United States

About this study

Official title: Ultrasound Based Acoustic Radiation Force Impulse, Shear Wave Velocity Imaging in Pediatric Patients Undergoing Liver Biopsy

ARFI (Ultrasound-based Acoustic Radiation Force Impulse) will be used during ultrasound guided needle biopsy of the liver of children.

Read the detailed description

A new technique based on ultrasound, known as Acoustic Radiation Force Impulse (ARFI) imaging is performed using standard approved ultrasound machines and transducers. The sound waves or impulses are generated in a different pattern and offer information on the stiffness of the tissue. This new technique will be evaluated for usefulness in diagnosing different liver conditions.

Conditions: Liver Fibrosis, Liver Inflammation
Being tested: Ultrasound-Based Acoustic Radiation Force Impulse (ARFI)
Medical subject headings: Liver Cirrhosis, Hepatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ultrasound-Based Acoustic Radiation Force Impulse (ARFI)Device
Research scans using ultrasound-based acoustic radiation force impulse (ARFI) will image the liver non-invasively.

Study groups in NCT01781208
Study group	Role	What they receive
Ultrasound-based Acoustic Radiation Force Imaging	Experimental	The liver was scanned using ultrasound and ultrasound-based acoustic radiation force impulse imaging technique (ARFI). Receives: Device: Ultrasound-Based Acoustic Radiation Force Impulse (ARFI)

What is being measured

The primary outcome is the main question the study is designed to answer.

ARFI/VTQ and ARFI/VTIQ Liver Shear Wave Speed vs. Liver Histologic Fibrosis Score
Tissue shear wave speed is positively correlated to a material's/tissue's stiffness and can be noninvasively measured by ultrasound. The relationship between liver shear wave speed and liver histologic fibrosis score were assessed using 2 different ultrasound methods. Liver shear wave speed as obtained using 2 different ultrasound methods served as our primary outcome measures.
Note, the histologic scoring system (Ishak) ranged from 0 to 6, where 0 = no fibrosis and 6 = cirrhosis.
Measured: 10 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2012May 2015

First posted31 Jan 2013 (estimated)
Study startNov 2012
Primary completionMay 2015
Study completionMay 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Liver FibrosisStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 62 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01781208
Sponsor's protocol ID: HUM00063736
Status last verified: Aug 2016
First submitted: 29 Jan 2013
Last updated: 21 Oct 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Liver Fibrosis trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ultrasound Based Acoustic Radiation Force Impulse, Shear Wave Velocity Imaging in Pediatric Patients Undergoing Liver Biopsy
ClinicalTrials.gov ID: NCT01781208
Acronym / sponsor ID: HUM00063736
Conditions: Liver Fibrosis, Liver Inflammation
Study type: Interventional
Recruitment status: Completed
Enrolment: 62 participants (actual)
Lead sponsor: University of MichiganUniversity, hospital or other
Study start: Nov 2012
Primary completion: May 2015 (actual)
Study completion: May 2015 (actual)
First posted: 31 Jan 2013 (estimated)
Results: Posted 21 Oct 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

ARFI (Ultrasound-based Acoustic Radiation Force Impulse) will be used during ultrasound guided needle biopsy of the liver of children.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Ultrasound-based Acoustic Radiation Force Imaging	Experimental	Device: Ultrasound-Based Acoustic Radiation Force Impulse (ARFI)The liver was scanned using ultrasound and ultrasound-based acoustic radiation force impulse imaging technique (ARFI).

Who may qualify

Ages: Up to 18 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (5 listed)

18 years of age or younger
Scheduled to have a needle biopsy of the liver at
Scheduled to have an abdominal ultrasound to evaluate your liver (with no known liver disease)

Key exclusion criteria (1 listed)

None to list

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-Based Acoustic Radiation Force Impulse (ARFI)Research scans using ultrasound-based acoustic radiation force impulse (ARFI) will image the liver non-invasively.	Device	Ultrasound-based Acoustic Radiation Force Imaging

Primary outcome

ARFI/VTQ and ARFI/VTIQ Liver Shear Wave Speed vs. Liver Histologic Fibrosis Score
Time frame: 10 minutes
Tissue shear wave speed is positively correlated to a material's/tissue's stiffness and can be noninvasively measured by ultrasound. The relationship between liver shear wave speed and liver histologic fibrosis score were assessed using 2 different ultrasound methods. Liver shear wave speed as obtained using 2 different ultrasound methods served as our primary outcome measures. Note, the histologic scoring system (Ishak) ranged from 0 to 6, where 0 = no fibrosis and 6 = cirrhosis.

Results and safety

Results posted to the registry on 21 Oct 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ultrasound-based Acoustic Radiation Force Impulse (ARFI)	62	62

Primary outcome: ARFI/VTQ and ARFI/VTIQ Liver Shear Wave Speed vs. Liver Histologic Fibrosis Score

Time frame: 10 minutes. Mean (Standard Deviation). Unit: m/s

Measure	Children Undergoing Diagnostic ARFI/VTQ and Fibrosis Scoring n = 49	Children Undergoing Diagnostic ARFI/VTIQ and Fibrosis Scoring n = 48
Value	1.69 (0.42)	2.01 (0.58)

Children Undergoing Diagnostic ARFI/VTQ and Fibrosis Scoring: p <0.0001, Pearson Correlation
Children Undergoing Diagnostic ARFI/VTIQ and Fibrosis Scoring: p <0.0001, Pearson Correlation

Population analysed: 49 pediatric subjects underwent successful (diagnostic) liver ARFI/VTQ) assessment and liver histologic fibrosis scoring. 13 subjects had non-diagnostic ARFI/VTQ exams. 48 pediatric subjects underwent successful (diagnostic) liver ARFI/VTIQ) assessment and liver histologic fibrosis scoring. 14 subjects had non-diagnostic ARFI/VTIQ exams.

Adverse events

Time frame: 19 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants	0 of 62 (0%)	0 of 62 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Liver Fibrosis

Not yet recruitingObservational study
A Study of Fatigue, Itching and Daily Activities in People With Primary Biliary Cholangitis Starting Elafibranor
Primary Biliary Cholangitis (PBC)
RecruitingPhase 3
Fenofibrate for Patients With Primary Biliary Cirrhosis Who Had An Inadequate Response to Ursodeoxycholic Acid
Primary Biliary Cirrhosis
RecruitingPhase 2/3
Fenofibrate in Patients With Primary Biliary Cholangitis (PBC)
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Enrolling by invitationPhase 2/3
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Primary Biliary Cholangitis (PBC)

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.

Jonathan Dillman, M.D. principal investigator

University of Michigan Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Ultrasound-Based Acoustic Radiation Force Impulse (ARFI) in people with Liver Fibrosis and Liver Inflammation, 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 5 inclusion and 1 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 21 Oct 2016. 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?

Yes. Results are posted in the registry (first posted 21 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

ARFI/VTQ and ARFI/VTIQ Liver Shear Wave Speed vs. Liver Histologic Fibrosis Score (time frame: 10 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01781208.

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 21 Oct 2016.