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

May 22, 2023 updated by: Rennes University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49033
        • CHU Angers
      • Clichy, France, 92118
        • Hôpital Beaujon
      • Lille, France, 59037
        • Hopital Huriez
      • Lyon, France, 69003
        • Hôpital Edouard Herriot
      • Marseille, France, 13385
        • Hôpital de la Timone
      • Montpellier, France, 34000
        • Hôpital Saint Eloi
      • Paris, France, 75970
        • Hopital Tenon
      • Rennes, France, 35033
        • Hôpital de Pontchaillou
      • Vandoeuvre les Nancy, France, 54511
        • Hôpital du Brabois
  • Spain
      • San Sebastian, Spain
        • Hopital Donostia-San Sebastian

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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,...).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Collaborators

Ministry of Health, France

Investigators

  • Study Director: Yves Gandon, MD, Rennes University Hospital
  • Study Chair: Eric BELLISSANT, MD, PhD, Rennes University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

November 17, 2006

First Submitted That Met QC Criteria

November 17, 2006

First Posted (Estimate)

November 20, 2006

Study Record Updates

Last Update Posted (Actual)

May 24, 2023

Last Update Submitted That Met QC Criteria

May 22, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DGS 2006/0197
  • PHRC/04-08
  • CIC0203/044

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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