Detection of Liver Fibrosis With Magnetic Resonance Imaging (MRI)



Status:Completed
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:3/13/2019
Start Date:October 2010
End Date:July 31, 2017

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

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.

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.
We found this trial at
1
site
1428 Madison Ave
New York, New York 10029
(212) 241-6500
Principal Investigator: Bachir Taouli, MD
Phone: 212-824-8475
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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mi
from
New York, NY
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