Quantification of Liver Iron Overload and Steatosis Using Magnetic Resonance Imaging (SURFER)

Rennes University Hospital

Status: Completed

Conditions: Hepatitis C; Iron Overload; Alcohol Abuse; Hepatitis B; Metabolic Syndrome X

Treatments: Device: Magnetic resonance imaging multiecho gradient-echo sequence

Study type: Interventional

Funder types: Other

Identifiers

NCT00401336

CIC0203/044

PHRC/04-08

DGS 2006/0197

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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,...).

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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250 participants in 1 patient group

Magnetic Resonance Imaging

Experimental group

Description:

New magnetic resonance imaging multiecho gradient-echo sequence

Treatment:

Device: Magnetic resonance imaging multiecho gradient-echo sequence