Sonoelastography: Ultrasound Method to Measure Liver Fibrosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Anthony Samir, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01747772
First received: October 31, 2012
Last updated: January 8, 2014
Last verified: January 2014
  Purpose

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

  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

Condition Intervention
Chronic Liver Disease
Non-Alcoholic Fatty Liver Disease
HCV Coinfection
HBV
Drug-Induced Liver Injury
Device: Shear Wave sonoelastography

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Diagnostic
Official Title: Evaluate the Utility of Shear Wave Sonoelastography as a Tool to Measure Liver Fibrosis Grade.

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • The ROC curve of the capacity of the continuous measure of liver elasticity (measured in kilopascals) to differentiate cirrhosis from lesser degree of liver fibrosis. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: February 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Shear Wave Sonoelastography, Fibrosis
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 from liver biopsy.
Other Name: Supersonic Aixplorer

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients (age 18 or older)
  • Men or women
  • Suspected diffuse 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 or sonoelastography.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01747772

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Anthony E Samir, MD    617-852-3241    asamir@partners.org   
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Anthony E Samir, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Anthony Samir, Associate Director, Ultrasound Imaging Services Assistant Radiologist, Abdominal Imaging & Intervention Massachusetts General Hospital, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01747772     History of Changes
Other Study ID Numbers: 2009P002791
Study First Received: October 31, 2012
Last Updated: January 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Non-focal Liver Disease
Fibrosis
Shear Wave Sonoelastography
Metavir Liver Fibrosis Grading

Additional relevant MeSH terms:
Fatty Liver
Fibrosis
Liver Diseases
Liver Cirrhosis
Coinfection
Drug-Induced Liver Injury
Wounds and Injuries
Hepatitis C
Digestive System Diseases
Pathologic Processes
Infection
Virus Diseases
Parasitic Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Poisoning
Hepatitis, Viral, Human
Flaviviridae Infections
RNA Virus Infections
Hepatitis

ClinicalTrials.gov processed this record on August 18, 2014