NCT02086708

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 13, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

February 1, 2017

Completed
Last Updated

February 1, 2017

Status Verified

December 1, 2016

Enrollment Period

4.8 years

First QC Date

March 7, 2014

Results QC Date

October 5, 2016

Last Update Submit

December 6, 2016

Conditions

Chronic Liver DiseaseNon-Alcoholic Fatty Liver DiseaseHCV CoinfectionHBVDrug-Induced Liver Injury

Keywords

Sonoelastography,Diffuse liver disease,chronic liver disease,NASH,NAFLD,Elevated Transaminases,Liver Biopsy,Fibrosis,METAVIR

Outcome Measures

Primary Outcomes (1)

  • 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).

    Day one

Study Arms (1)

Shear Wave Sonoelastography, Fibrosis stage

EXPERIMENTAL

Shear Wave sonoelastography is performed on patients who are scheduled for a non-focal liver biopsy.

Device: Shear Wave sonoelastography

Interventions

Shear Wave sonoelastographyDEVICE

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.

Also known as: Supersonic Aixplorer
Shear Wave Sonoelastography, Fibrosis stage

Eligibility Criteria

Age1 Year - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • 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.

    PMID: 26503488RESULT

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseChemical and Drug Induced Liver InjuryFibrosis

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System DiseasesDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersPoisoningPathologic ProcessesPathological Conditions, Signs and Symptoms

Limitations and Caveats

This was meant to be a feasibility study to show that shear-wave sonoelastography can be performed in the pediatric age group.

Results Point of Contact

Title
Dr. Uzma Shah
Organization
Massachusetts General Hospital
USHAH@mgh.harvard.edu
617-726-1450

Study Officials

  • Uzma Shah, MD, FAAP

    Massachusetss General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor in Pediatrics, Massachusetts General Hospital for Children, Harvard Medi

Study Record Dates

First Submitted

March 7, 2014

First Posted

March 13, 2014

Study Start

June 1, 2010

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

February 1, 2017

Results First Posted

February 1, 2017

Record last verified: 2016-12

Locations

US(1)