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Prospective Detection of Liver Fibrosis With MRI Compared to Fibroscan and Blood Tests


N/A
18 Years
N/A
Open (Enrolling)
Both
Chronic Liver Disease

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Trial Information

Prospective Detection of Liver Fibrosis With MRI Compared to Fibroscan and Blood Tests


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.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

degree of liver fibrosis

Outcome Description:

Accuracy of prediction of degree of liver fibrosis using non invasive MRI methods

Outcome Time Frame:

baseline

Safety Issue:

No

Principal Investigator

Bachir Taouli, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mount Sinai School of Medicine

Authority:

United States: Food and Drug Administration

Study ID:

GCO 09-1187

NCT ID:

NCT01600105

Start Date:

May 2010

Completion Date:

June 2015

Related Keywords:

  • Chronic Liver Disease
  • liver fibrosis
  • liver cirrhosis
  • chronic hepatitis
  • magnetic resonance imaging
  • Fibrosis
  • Liver Diseases
  • Liver Cirrhosis

Name

Location

Mount Sinai School of MedicineNew York, New York  10029