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Detection of Liver Fibrosis With Magnetic Resonance Imaging (MRI)

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ClinicalTrials.gov Identifier: NCT01600105
Recruitment Status : Completed
First Posted : May 16, 2012
Last Update Posted : October 24, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
Patients with chronic liver disease are at high risk of developing liver scarring (fibrosis), with ultimate risks of cirrhosis and liver cancer that may require liver transplant. The investigators would like to develop non invasive advanced Magnetic Resonance Imaging (MRI) techniques (MR diffusion, perfusion and elastography) to assess the degree of liver damage in patients with chronic liver disease. These techniques combined could reach high diagnostic performance for detection of liver fibrosis; and could decrease the number of liver biopsies, which have risks and sample only a small portion of the liver.

Condition or disease Intervention/treatment Phase
Chronic Liver Disease Drug: Perfusion MRI Phase 4

Detailed Description:

Patients with chronic hepatitis have increased risks of liver damage, including fibrosis and cirrhosis, which may eventually lead to hepatocellular carcinoma and end-stage liver disease requiring liver transplantation. These diseases are/will be the source of enormous health care costs and morbidity/mortality in the US.

Most hepatologists still rely on liver biopsy findings in patients newly diagnosed with chronic hepatitis, which enables the assessment of liver damage (fibrosis and inflammation). Liver biopsy has limitations, including cost, invasiveness, poor patient acceptance, limited sampling, inter-observer variability and is difficult to repeat.

Non invasive tests to capture the extent of liver damage at a larger scale are urgently needed. These will gain more acceptance among patients and hepatologists.

In this proposal, the investigators would like to test and validate non invasive MRI methods based on advanced MR diffusion, perfusion and elastography techniques for the detection of fibrosis and cirrhosis in patients with chronic hepatitis. In order to improve the diagnostic performance of MRI, the investigators would like to build and validate a predictive model based on advanced functional MRI metrics (diffusion, perfusion and elastography). If validated, this novel non invasive algorithm will not only decreases the number of liver biopsies, but also enable earlier diagnosis of liver fibrosis when antiviral treatment is more effective, and enable a comprehensive evaluation of the liver (to assess for cirrhosis, portal hypertension and hepatocellular cancer).

This could significantly reduce the cost of care, could become a useful tool for testing new antifibrogenic and antiviral drugs in chronic viral hepatitis, and could be used to follow patients for detection of progression to cirrhosis.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 266 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prospective Detection of Liver Fibrosis With MRI Compared to Fibroscan and Blood Tests
Study Start Date : May 2010
Primary Completion Date : July 31, 2017
Study Completion Date : July 31, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Perfusion MRI
chronic liver disease who underwent/will undergo liver biopsy or will undergo liver transplant or liver resection as part of standard care during the previous 6 months.
Drug: Perfusion MRI
1) Assess the role of a new FDA approved blood pool gadolinium contrast agent (gadofosveset trisodium, Ablavar, Lantheus) for the measurement of liver MR Perfusion, compared to extra-cellular contrast agents.
Other Names:
  • Dynamic contrast-enhanced MRI
  • Perfusion MRI (adofosveset trisodium, Ablavar, Lantheus)

Outcome Measures

Primary Outcome Measures :
  1. degree of liver fibrosis [ Time Frame: baseline ]
    Accuracy of prediction of degree of liver fibrosis using non invasive MRI methods

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Chronic liver disease (including viral hepatitis, alcoholic hepatitis, non alcoholic steatohepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, etc..)
  • 18 years of age and older
  • Liver biopsy (percutaneous or transjugular or surgical) performed within 6 months, as part of routine clinical care.
  • Liver transplant or liver resection performed within 6 months, as part of routine clinical care.
  • Patient is able to give informed consent for this study and agrees to provide a blood sample

Control group

  • Patients without history of liver disease and healthy volunteers
  • 18 years of age and older
  • Subject is able to give informed consent for this study and agrees to provide a blood sample

Exclusion Criteria:

  • Age less than 18 years
  • Unable or unwilling to give informed consent
  • Contra-indications to MRI
  • Electrical implants such as cardiac pacemakers or perfusion pumps
  • Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants
  • Ferromagnetic objects such as jewelry or metal clips in clothing
  • Pregnant subjects
  • Pre-existing medical conditions including a likelihood of developing seizures or claustrophobic reactions.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01600105

United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Bachir Taouli
Principal Investigator: Bachir Taouli, MD Icahn School of Medicine at Mount Sinai
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bachir Taouli, Associate Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01600105     History of Changes
Other Study ID Numbers: GCO 09-1187
First Posted: May 16, 2012    Key Record Dates
Last Update Posted: October 24, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bachir Taouli, Icahn School of Medicine at Mount Sinai:
liver fibrosis
liver cirrhosis
chronic hepatitis
magnetic resonance imaging

Additional relevant MeSH terms:
Liver Diseases
Liver Cirrhosis
Pathologic Processes
Digestive System Diseases
Liver Extracts