Chronic Liver DiseaseNCT02086708

Ultrasound Method to Measure Fibrosis of the Liver in Children

A study testing Shear Wave sonoelastography in people with Chronic Liver Disease and Non-Alcoholic Fatty Liver Disease, run by Massachusetts General Hospital at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

HYPOTHESIS: The investigators hypothesize that sonoelastography (SE) provide accurate quantitative measurements that can be used to stage liver fibrosis in pediatric patients with chronic liver disease. Read more about this study

Who is it for?: Ages 1 year to 21 years
Conditions the study is for: Chronic Liver Disease, Non-Alcoholic Fatty Liver Disease, HCV Coinfection
What is being tested?: Shear Wave sonoelastography
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited States
Study dates: Jun 2010to Mar 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 1 year to 21 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Patients scheduled for random liver biopsy for routine staging of liver fibrosis
Pediatric patients patients (ages 1-21)
Girls or boys
Suspected liver disease
Consent to participate in the study

Who cannot join

Pregnancy
Acute illness/cognitive impairment resulting in inability to cooperate with ultrasound
Patients that do not consent to ultrasound guided liver biopsy.
Contraindications to liver biopsy (e.g. low platelets defined as a platelet count of less than 50,000, and hemophilia/coagulopathy as an INR higher than 1.5.)

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hospital
Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: Sonoelastography: Ultrasound Method to Measure Fibrosis of the Liver in Children

Specific Aims:

To measure liver stiffness with sonoelastography in pediatric and adolescents with suspect diffuse liver disease who will undergo nonfocal liver biopsy as part of their routine clinical care.

Conditions: Chronic Liver Disease, Non-Alcoholic Fatty Liver Disease, HCV Coinfection, HBV, Drug-Induced Liver Injury
Being tested: Shear Wave sonoelastography
Keywords: Sonoelastography,, Diffuse liver disease,, chronic liver disease,, NASH,, NAFLD,, Elevated Transaminases,, Liver Biopsy,, Fibrosis,, METAVIR
Medical subject headings: Non-alcoholic Fatty Liver Disease, Chemical and Drug Induced Liver Injury, Fibrosis

What participants receive

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

Shear Wave sonoelastographyDevice
Also called Supersonic Aixplorer
Shear Wave Sonoelastography as a ultrasound technique to measure liver fibrosis is performed on patients scheduled for non-focal liver biopsy. Results are compared with pathological score of fibrosis from liver biopsy.

Study groups in NCT02086708
Study group	Role	What they receive
Shear Wave Sonoelastography, Fibrosis stage	Experimental	Shear Wave sonoelastography is performed on patients who are scheduled for a non-focal liver biopsy. Receives: Device: Shear Wave sonoelastography

What is being measured

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

Measure Liver Elasticity Value Using Sonoelastography.
Assess liver stiffness as measured by sonoelastography with results of liver biopsy as read by a single-pathologist using the METAVIR criteria (F0-F4).
Measured: Day one

Timeline

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

Jun 2010Mar 2015

First posted13 Mar 2014 (estimated)
Study startJun 2010
Primary completionMar 2015
Study completionMar 2015

Why it stopped: The technology showed rapid acceptance in the general population and we halted our feasibility demonstration study.

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Liver DiseaseStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe 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: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02086708
Sponsor's protocol ID: 2010P000705
Status last verified: Dec 2016
First submitted: 7 Mar 2014
Last updated: 1 Feb 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Undecided

Publications

Dhyani M, Gee MS, Misdraji J, Israel EJ, Shah U, Samir AE. Feasibility study for assessing liver fibrosis in paediatric and adolescent patients using real-time shear wave elastography. J Med Imaging Radiat Oncol. 2015 Dec;59(6):687-94; quiz 751. doi: 10.1111/1754-9485.12388. Epub 2015 Oct 27.
PubMed 26503488

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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Study at a glance

From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Sonoelastography: Ultrasound Method to Measure Fibrosis of the Liver in Children
ClinicalTrials.gov ID: NCT02086708
Acronym / sponsor ID: 2010P000705
Conditions: Chronic Liver Disease, Non-Alcoholic Fatty Liver Disease, HCV Coinfection, HBV, Drug-Induced Liver Injury
Keywords: Sonoelastography,, Diffuse liver disease,, chronic liver disease,, NASH,, NAFLD,, Elevated Transaminases,, Liver Biopsy,, Fibrosis,
Study type: Interventional
Recruitment status: TerminatedReason stopped: The technology showed rapid acceptance in the general population and we halted our feasibility demonstration study.
Enrolment: 24 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Study start: Jun 2010
Primary completion: Mar 2015 (actual)
Study completion: Mar 2015 (actual)
First posted: 13 Mar 2014 (estimated)
Results: Posted 1 Feb 2017

Clinical summary

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

Specific Aims:

To measure liver stiffness with sonoelastography in pediatric and adolescents with suspect diffuse liver disease who will undergo nonfocal liver biopsy as part of their routine clinical care.

Study design

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

Arm	Type	Receives
Shear Wave Sonoelastography, Fibrosis stage	Experimental	Device: Shear Wave sonoelastographyShear Wave sonoelastography is performed on patients who are scheduled for a non-focal liver biopsy.

Who may qualify

Ages: 1 year to 21 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (5 listed)

Patients scheduled for random liver biopsy for routine staging of liver fibrosis
Pediatric patients patients (ages 1-21)
Girls or boys
Suspected liver disease
Consent to participate in the study

Key exclusion criteria (4 listed)

Pregnancy
Acute illness/cognitive impairment resulting in inability to cooperate with ultrasound
Patients that do not consent to ultrasound guided liver biopsy.
Contraindications to liver biopsy (e.g. low platelets defined as a platelet count of less than 50,000, and hemophilia/coagulopathy as an INR higher than 1.5.)

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
Shear Wave sonoelastographyAlso: Supersonic AixplorerShear Wave Sonoelastography as a ultrasound technique to measure liver fibrosis is performed on patients scheduled for non-focal liver biopsy. Results are compared with pathological score of fibrosis from liver biopsy.	Device	Shear Wave Sonoelastography, Fibrosis stage

Primary outcome

Measure Liver Elasticity Value Using Sonoelastography.
Time frame: Day one
Assess liver stiffness as measured by sonoelastography with results of liver biopsy as read by a single-pathologist using the METAVIR criteria (F0-F4).

Results and safety

Results posted to the registry on 1 Feb 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Shear Wave Sonoelastography, Fibrosis	24	24

Primary outcome: Measure Liver Elasticity Value Using Sonoelastography.

Time frame: Day one. Mean (95% Confidence Interval). Unit: kPa

Measure	Fibrosis 0 n = 10	Fibrosis 1 n = 9	Fibrosis 2 n = 1	Fibrosis 3 n = 3	Fibrosis 4 n = 1
Value	6.93 (6.33 to 7.44)	8.33 (6.83 to 10.80)	6.12 (NA to NA)	8.86 (5.7 to 11.4)	17.85 (NA to NA)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fibrosis 0	0 of 10 (0%)	0 of 10 (0%)	Not reported
Fibrosis 1	0 of 9 (0%)	0 of 9 (0%)	Not reported
Fibrosis 2	0 of 1 (0%)	0 of 1 (0%)	Not reported
Fibrosis 3	0 of 3 (0%)	0 of 3 (0%)	Not reported
Fibrosis 4	0 of 1 (0%)	0 of 1 (0%)	Not reported

Limitations and caveats (from the sponsor): This was meant to be a feasibility study to show that shear-wave sonoelastography can be performed in the pediatric age group.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 26503488Dhyani M, Gee MS, Misdraji J, Israel EJ, Shah U, Samir AE. Feasibility study for assessing liver fibrosis in paediatric and adolescent patients using real-time shear wave elastography. J Med Imaging Radiat Oncol. 2015 Dec;59(6):687-94; quiz 751. doi: 10.1111/1754-9485.12388. Epub 2015 Oct 27.
Individual participant dataSharing planned: Undecided

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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.

Uzma Shah, MD, FAAP principal investigator

Massachusetss General 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 Shear Wave sonoelastography in people with Chronic Liver Disease and Non-Alcoholic Fatty Liver Disease, run by Massachusetts General Hospital 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 4 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: stopped early, as of the sponsor's last update on 1 Feb 2017. 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 1 Feb 2017). 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?

Measure Liver Elasticity Value Using Sonoelastography. (time frame: Day one). 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 NCT02086708, which also lists 1 linked publication.

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 1 Feb 2017.