Back to resultsUltrasound Method to Measure Fibrosis of the Liver in Children
Primary Purpose
Chronic Liver Disease, Non-Alcoholic Fatty Liver Disease, HCV Coinfection
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Shear Wave sonoelastography
Sponsored by
About this trial
This is an interventional diagnostic trial for Chronic Liver Disease focused on measuring Sonoelastography,, Diffuse liver disease,, chronic liver disease,, NASH,, NAFLD,, Elevated Transaminases,, Liver Biopsy,, Fibrosis,, METAVIR
Eligibility Criteria
Inclusion criteria:
- 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
Exclusion criteria:
- 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.)
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Shear Wave Sonoelastography, Fibrosis stage
Arm Description
Shear Wave sonoelastography is performed on patients who are scheduled for a non-focal liver biopsy.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT02086708
First Posted
March 7, 2014
Last Updated
December 6, 2016
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02086708
Brief Title
Ultrasound Method to Measure Fibrosis of the Liver in Children
Official Title
Sonoelastography: Ultrasound Method to Measure Fibrosis of the Liver in Children
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Terminated
Why Stopped
The technology showed rapid acceptance in the general population and we halted our feasibility demonstration study.
Study Start Date
June 2010 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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,, METAVIR
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Shear Wave Sonoelastography, Fibrosis stage
Arm Type
Experimental
Arm Description
Shear Wave sonoelastography is performed on patients who are scheduled for a non-focal liver biopsy.
Intervention Type
Device
Intervention Name(s)
Shear Wave sonoelastography
Other Intervention Name(s)
Supersonic Aixplorer
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measure Liver Elasticity Value Using Sonoelastography.
Description
Assess liver stiffness as measured by sonoelastography with results of liver biopsy as read by a single-pathologist using the METAVIR criteria (F0-F4).
Time Frame
Day one
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
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
Exclusion criteria:
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Uzma Shah, MD, FAAP
Organizational Affiliation
Massachusetss General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26503488
Citation
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.
Results Reference
result
Learn more about this trial
Ultrasound Method to Measure Fibrosis of the Liver in Children
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