Detection of Liver Fibrosis With Magnetic Resonance Imaging (MRI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Mount Sinai School of Medicine
Sponsor:
Information provided by (Responsible Party):
Bachir Taouli, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01600105
First received: May 14, 2012
Last updated: December 14, 2013
Last verified: December 2013
  Purpose

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 Intervention
Chronic Liver Disease
Drug: Perfusion MRI

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Prospective Detection of Liver Fibrosis With MRI Compared to Fibroscan and Blood Tests

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • degree of liver fibrosis [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Accuracy of prediction of degree of liver fibrosis using non invasive MRI methods


Estimated Enrollment: 100
Study Start Date: May 2010
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
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: NCT01600105

Contacts
Contact: Bachir Taouli, MD 212-824-8475 bachir.taouli@mountsinai.org

Locations
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Claudia Donnerhack    212-824-8475    claudia.donnerhack@mountsinai.org   
Principal Investigator: Bachir Taouli, MD         
Sponsors and Collaborators
Bachir Taouli
Investigators
Principal Investigator: Bachir Taouli, MD Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Bachir Taouli, Associate Professor, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01600105     History of Changes
Other Study ID Numbers: GCO 09-1187
Study First Received: May 14, 2012
Last Updated: December 14, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
liver fibrosis
liver cirrhosis
chronic hepatitis
magnetic resonance imaging

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

ClinicalTrials.gov processed this record on July 22, 2014