Ultrasound Method to Measure Fibrosis of the Liver in Children

Non-Alcoholic Fatty Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02086708
• Other study ID #: 2010P000705
• Status: Recruiting
• Phase: N/A
• First received: March 7, 2014
• Last updated: March 11, 2014
• Start date: June 2010
• Est. completion date: March 2015

Study information

• Verified date: March 2014
• Source: Massachusetts General Hospital
• Contact: Uzma Shah, MD, FAAP
• Phone: 617-726-0319
• Email: USHAH[@]partners.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

Specific Aims:

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

2. To assess the sensitivity and specificity of sonoelastography for the detection and staging of liver fibrosis.

3. To obtain sonoelastography values of the liver in healthy children (control subjects).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 18 Years

Eligibility

Inclusion criteria:

• Patients scheduled for random liver biopsy for routine staging of liver fibrosis

• Pediatric patients patients (ages 5-18)

• Girls or boys

• Suspected liver disease

• Consent to participate in the study

Inclusion criteria for Controls:-

• Patients scheduled for ultrasound examination (other than a liver biopsy)

• Pediatric patients (ages 5-18) without known liver disease

• Girls or boys

• No known 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.)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Chronic Liver Disease
• Coinfection
• Drug-Induced Liver Injury
• Fatty Liver
• HBV
• HCV Coinfection
• Liver Diseases
• Non-Alcoholic Fatty Liver Disease

Intervention

Device:
• Shear Wave sonoelastography
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 from liver biopsy.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the efficacy of sonoelastography in diagnosis stage of liver fibrosis	The study is designed to compare the assessment of liver stiffness as measured by sonoelastography with results of liver biopsy. Overall efficacy of sonoelastography in determining the stage of fibrosis will then be determined.	5 years (2010-2015)	No