Validation of 3.0 Tesla 1H-MR Spectroscopy for assessment of liver steatosis in patients with non-alcoholic fatty liver disease and chronically infected hepatitis C

Hepatic steatosis is fat accumulation in the liver. Hepatic steatosis is caused
by obesitas, diabetes and dyslipidemia, features of the metabolic syndrome. It
is estimated to be present in 30% of the western population. 10% of these
patients develop a more severe condition called non-alcoholic steatohepatitis
(NASH). Due to inflammation NASH eventually can develop into liver cirrhosis.
This process is called non-alcoholic fatty liver disease (NAFLD) and is at the
moment the most common chronic liver disease. Other causes of hepatic steatosis
are: alcohol induced hepatic steatosis, drug induced hepatic steatosis, chronic
hepatitis C infection and chemotherapy associated steatohepatitis (CASH).
Hepatic steatosis in CHC has a negative impact on treatment efficacy and
enhances the progression to fibrosis. Liver biopsy and histological examination
has been the reference standard for assessing hepatic steatosis, but major and
minor complications and sampling errors because of inhomogeneous distribution
of fat in the liver are reported. At the moment there is no suitable
non-invasive technique for quantifying hepatic steatosis. Proton Magnetic
Resonance Spectroscopy (1H-MRS) is a safe, non-invasive and repeatable
(non-ionizing) diagnostic tool that may allow quantifying various components of
fat such as saturated and unsaturated fatty acid chains. This technique is not
yet used as a standard clinical tool. We suggest that 3.0 Tesla (due to higher
spectral resolution than 1H-MRS at 1.5 Tesla, which provides better insight in
various fatty acid chians) 1H -MRS is a suitable and promising candidate for
quantitative assessment of hepatic steatosis.

Validation and quantification of 3.0 Tesla 1H *MRS for the assessment of
hepatic steatosis in patients with non alcoholic fatty liver disease and
patients chronically infected with hepatitis C. Is there a close correlation
between the 1H *MRS measurement of fat and histological assessment of fat from
liver biopsy? Is it possible to validate and quantify 1H *MRS, so it can be
used as a viable, repeatable, and non-invasive standard clinical tool for the
assessment of hepatic steatosis?

In this prospective pilot study the population consists of consecutive patients
with non-alcoholic fatty liver disease and patients with chronically infected
hepatitis C (all genotypes (1-6)) visiting the outpatient clinic of the AMC
Liver Center. Those who require a liver biopsy are being asked to participate.
After informed consent, patients are referred for 1H-MRS and ultrasonography of
the liver consequently followed or preceded by liver biopsy. Histological
evaluation of the liver biopsy will be compared to the amount of fat measured
by 1H-MRS for validation and correlation studies. Liver biopsy and 1H -MRS will
be performed in the same part of the liver.

The patients in this study will undergo 1H-MRS, ultrasonography and liver
biopsy. Liver biopsy will only be performed when clinically indicated. A liver
biopsy is not without harm, with reported major and minor complications rates
of 1% and 13.6%, respectively. The most reported complications are bleeding,
shoulder pain and biliairy leakage. 1H-MRS is a non-invasive, non-ionizing 45
minute examination in the MRI scanner, which requires one extra visit to the
hospital. Blood tests and ultrasonography are indicated for assessing disease
progression. Ultrasonography is also a harmless non-invasive, non ionizing
examination. No extra bloodtests will be needed. Patients are not delayed in
treatment for their disease. There will be little extra physical and
psychological discomfort associated with participation.