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
|Condition or disease||Intervention/treatment||Phase|
|Chronic Liver Disease||Drug: Perfusion MRI||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||266 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Detection of Liver Fibrosis With MRI Compared to Fibroscan and Blood Tests|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||July 31, 2017|
|Actual Study Completion Date :||July 31, 2017|
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.
- degree of liver fibrosis [ Time Frame: baseline ]Accuracy of prediction of degree of liver fibrosis using non invasive MRI methods
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|
|Principal Investigator:||Bachir Taouli, MD||Icahn School of Medicine at Mount Sinai|