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NCT Number: NCT00401336

Quantification of Liver Iron Overload and Steatosis Using Magnetic Resonance Imaging

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.

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Key information

Conditions

Iron Overload Alcohol Abuse Alcohol-Related Disorders Alcoholism Blood-Borne Infections Chemically-Induced Disorders Communicable Diseases DNA Virus Infections Digestive System Diseases Fatty Liver Flaviviridae Infections Glucose Metabolism Disorders Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis C Hepatitis, Viral, Human Hyperinsulinism Infections Insulin Resistance Iron Metabolism Disorders Liver Diseases Mental Disorders Metabolic Diseases Metabolic Syndrome Metabolic Syndrome X Nutritional and Metabolic Diseases RNA Virus Infections Substance-Related Disorders Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Angers, Angers, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,...).

Treatment and study plan

Magnetic resonance imaging multiecho gradient-echo sequence

Device

Breath-hold gradient echo sequences with a single echo and a new multiple-echo gradient-echo sequence

Primary outcomes

  1. Liver to muscle signal intensity ratio and T2* calculation versus liver iron concentration

    Time frame: during examination

Secondary outcomes

  1. Difference between in-phase and out-phase T2* calculation versus liver fat concentration

    Time frame: during examination

  2. Correlation between biochemical and MRI quantification of liver iron

    Time frame: during examination

  3. Correlation between participating centers

    Time frame: during examination

  4. Reproducibility of the multiecho gradient-echo sequence

    Time frame: during examination

  5. Influence of the antenna for the multiecho gradient-echo sequence

    Time frame: during examination

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study title

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

Acronym: SURFER

Important dates

Study start
2006
Primary completion
2013
Study completion
2013
First posted
Nov 20, 2006
Registry last updated
May 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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