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

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT00401336
First received: November 17, 2006
Last updated: March 7, 2013
Last verified: July 2012
  Purpose

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.


Condition Intervention
Iron Overload
Metabolic Syndrome X
Hepatitis B
Hepatitis C
Alcohol Abuse
Device: Magnetic resonance imaging multiecho gradient-echo sequence

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Quantification of Liver Iron Overload and Steatosis Using a New Magnetic Resonance Imaging Multiecho Gradient-echo Sequence

Resource links provided by NLM:


Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • Liver to muscle signal intensity ratio and T2* calculation versus liver iron concentration [ Time Frame: during examination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Difference between in-phase and out-phase T2* calculation versus liver fat concentration [ Time Frame: during examination ] [ Designated as safety issue: No ]
  • Correlation between biochemical and MRI quantification of liver iron [ Time Frame: during examination ] [ Designated as safety issue: No ]
  • Correlation between participating centers [ Time Frame: during examination ] [ Designated as safety issue: No ]
  • Reproducibility of the multiecho gradient-echo sequence [ Time Frame: during examination ] [ Designated as safety issue: No ]
  • Influence of the antenna for the multiecho gradient-echo sequence [ Time Frame: during examination ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: November 2006
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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,...).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00401336

Locations
France
CHU Angers
Angers, France, 49033
Hôpital Beaujon
Clichy, France, 92118
Hôpital Huriez
Lille, France, 59037
Hôpital Edouard Herriot
Lyon, France, 69003
Hôpital de la Timone
Marseille, France, 13385
Hôpital Saint Eloi
Montpellier, France, 34000
Hôpital Tenon
Paris, France, 75970
Hôpital de Pontchaillou
Rennes, France, 35033
Hôpital du Brabois
Vandoeuvre les Nancy, France, 54511
Spain
Hopital Donostia-San Sebastian
San Sebastian, Spain
Sponsors and Collaborators
Rennes University Hospital
Ministry of Health, France
Investigators
Study Director: Yves Gandon, MD Rennes University Hospital
Study Chair: Eric Bellissant, MD, PhD Rennes University Hospital
  More Information

No publications provided

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT00401336     History of Changes
Other Study ID Numbers: DGS 2006/0197, PHRC/04-08, CIC0203/044
Study First Received: November 17, 2006
Last Updated: March 7, 2013
Health Authority: France: Direction Générale de la Santé

Keywords provided by Rennes University Hospital:
Magnetic resonance imaging
Hepatic iron
Steatosis

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis C
Alcoholism
Iron Overload
Metabolic Syndrome X
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Flaviviridae Infections
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Iron Metabolism Disorders
Metabolic Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on April 16, 2014