Quantification of Liver Iron Overload and Steatosis Using Magnetic Resonance Imaging (SURFER)
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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 |
- Liver to muscle signal intensity ratio and T2* calculation versus liver iron concentration [ Time Frame: during examination ] [ Designated as safety issue: No ]
- 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 |
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| 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 | |
| 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 June 18, 2013