Ultrasound Method to Measure Fibrosis of the Liver in Children

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02086708
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arm: 1
• Duration (Months): 57
• Patients Per Site Per Month: 0.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Liver Disease; Non-Alcoholic Fatty Liver Disease; HCV Coinfection; HBV; Drug-Induced Liver Injury	Device: Shear Wave sonoelastography	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Sonoelastography: Ultrasound Method to Measure Fibrosis of the Liver in Children
• Study Start Date: Jun 1, 2010
• Actual Primary Completion Date: Mar 1, 2015
• Actual Study Completion Date: Mar 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Shear Wave Sonoelastography, Fibrosis stage Shear Wave sonoelastography is performed on patients who are scheduled for a non-focal liver biopsy.	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 of fibrosis from liver biopsy.; Other Names: Supersonic Aixplorer

Outcome Measures

Primary Outcome Measures

1. Measure Liver Elasticity Value Using Sonoelastography. [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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 21 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Massachusetts General Hospital

Investigators

• Principal Investigator: Uzma Shah, MD, FAAP, Massachusetss General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Uzma Shah, MD, Associate Professor in Pediatrics, Massachusetts General Hospital for Children, Harvard Medi, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT02086708
• Other Study ID Numbers: 2010P000705
• First Posted: Mar 13, 2014
• Last Update Posted: Feb 1, 2017
• Last Verified: Dec 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Uzma Shah, MD, Associate Professor in Pediatrics, Massachusetts General Hospital for Children, Harvard Medi, Massachusetts General Hospital: Sonoelastography,; Diffuse liver disease,; chronic liver disease,; NASH,; NAFLD,; Elevated Transaminases,; Liver Biopsy,; Fibrosis,; METAVIR
• Additional relevant MeSH terms: Coinfection; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Chemical and Drug Induced Liver Injury; Fibrosis

Study Results

Participant Flow

Recruitment Details	1. Patients scheduled for Liver Biopsy 2.

Arm/Group Title	Shear Wave Sonoelastography, Fibrosis
Arm/Group Description	Shear Wave sonoelastography is performed on patients who are scheduled for a non-focal liver biopsy. 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.
Period Title: Overall Study
STARTED	24
COMPLETED	24
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Shear Wave Sonoelastography, Fibrosis
Arm/Group Description	Shear Wave sonoelastography is performed on patients who are scheduled for a non-focal liver biopsy. 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.
Overall Participants	24
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	17
Gender (Count of Participants)
Female	11 45.8%
Male	13 54.2%
Region of Enrollment (participants) [Number]
United States	24 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fibrosis 0	Fibrosis 1	Fibrosis 2	Fibrosis 3	Fibrosis 4
Arm/Group Description	Patients with no Fibrosis on liver biopsy evaluation	Patients with liver biopsy METAVIR stage 1 on pathology evaluation	Patients with liver biopsy METAVIR stage 2 on pathology evaluation	Patients with liver biopsy METAVIR stage 3 on pathology evaluation	Patients with liver biopsy METAVIR stage 4 on pathology evaluation
Measure Participants	10	9	1	3	1
Mean (95% Confidence Interval) [kPa]	6.93	8.33	6.12	8.86	17.85

Adverse Events

Arm/Group Title	Fibrosis 0		Fibrosis 1		Fibrosis 2		Fibrosis 3		Fibrosis 4
Arm/Group Description	Patients with no Fibrosis on liver biopsy evaluation		Patients with liver biopsy METAVIR stage 1 on pathology evaluation		Patients with liver biopsy METAVIR stage 2 on pathology evaluation		Patients with liver biopsy METAVIR stage 3 on pathology evaluation		Patients with liver biopsy METAVIR stage 4 on pathology evaluation
All Cause Mortality
	Fibrosis 0		Fibrosis 1		Fibrosis 2		Fibrosis 3		Fibrosis 4
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Fibrosis 0		Fibrosis 1		Fibrosis 2		Fibrosis 3		Fibrosis 4
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/9 (0%)		0/1 (0%)		0/3 (0%)		0/1 (0%)
Other (Not Including Serious) Adverse Events
	Fibrosis 0		Fibrosis 1		Fibrosis 2		Fibrosis 3		Fibrosis 4
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/9 (0%)		0/1 (0%)		0/3 (0%)		0/1 (0%)

Limitations/Caveats

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

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.