Quantification of Liver Iron Overload and Steatosis Using Magnetic Resonance Imaging

Study Overview
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Brief Summary
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Iron excess is increasingly regarded as an important cofactor in the morbidity attributed to many disorders. Assessment of body iron stores by measurement of serum ferritin concentrations has poor specificity and the most reliable method is histological or biochemical assessment from a liver biopsy. Because liver biopsy is an invasive procedure, imaging methods have been developed to detect and quantify hepatic iron content. The aim of the study is to use a simplified magnetic resonance imaging (MRI) technique to quantify simultaneously iron and fat contents in the liver and to compare the results to the quantification obtained biochemically.

Detailed Description
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Iron excess is increasingly regarded as an important cofactor in the morbidity attributed to many disorders. Assessment of body iron stores by measurement of serum ferritin concentrations has poor specificity and the most reliable method is histological or biochemical assessment from a liver biopsy. Because liver biopsy is an invasive procedure, imaging methods have been developed to detect and quantify hepatic iron content. The aim of the study is to use a simplified magnetic resonance imaging technique to quantify simultaneously iron and fat contents in the liver and to compare the results to the quantification obtained biochemically. Patients who need a liver biopsy will be proposed to be enrolled in the study. A magnetic resonance (MR) study will be performed using breath-hold gradient echo sequences with a single echo and a new multiple-echo gradient-echo sequence. Liver and muscle MR signal will be quantitatively determined and compared to biochemical assessment of liver iron concentration and steatosis quantification.

Official Title
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Quantification of Liver Iron Overload and Steatosis Using a New Magnetic Resonance Imaging Multiecho Gradient-echo Sequence

Conditions
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Iron Overload, Metabolic Syndrome X, Hepatitis B, Hepatitis C, Alcohol Abuse

Intervention / Treatment
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* Device: Magnetic resonance imaging multiecho gradient-echo sequence


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults over 18, Planned liver biopsy (or liver biopsy within 2 months before inclusion) for one of these indications: suspicion of liver iron overload, metabolic syndrome, hepatitis B or C, alcohol abuse. No change in diet, transfusions or iron depletion must have occur between the liver biopsy and the MRI. Having given a written informed consent. Exclusion Criteria: Non cooperating patient, Patient with dyspnea, Patient with contra-indication to MR imaging (pace-maker, heart valve,...).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Magnetic Resonance Imaging<br>New magnetic resonance imaging multiecho gradient-echo sequence | Device: Magnetic resonance imaging multiecho gradient-echo sequence<br>* Breath-hold gradient echo sequences with a single echo and a new multiple-echo gradient-echo sequence<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver to muscle signal intensity ratio and T2* calculation versus liver iron concentration |  | during examination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between in-phase and out-phase T2* calculation versus liver fat concentration |  | during examination | 
| Correlation between biochemical and MRI quantification of liver iron |  | during examination | 
| Correlation between participating centers |  | during examination | 
| Reproducibility of the multiecho gradient-echo sequence |  | during examination | 
| Influence of the antenna for the multiecho gradient-echo sequence |  | during examination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Magnetic resonance imaging, Hepatic iron, Steatosis