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| Sponsors and Collaborators: |
Rennes University Hospital Ministry of Health, France |
|---|---|
| Information provided by: | Rennes University Hospital |
| ClinicalTrials.gov Identifier: | NCT00401336 |
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: | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
| Official Title: | Quantification of Liver Iron Overload and Steatosis Using a New Magnetic Resonance Imaging Multiecho Gradient-Echo Sequence |
| Estimated Enrollment: | 250 |
| Study Start Date: | November 2006 |
| Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Magnetic Resonance Imaging: Experimental
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
|
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:
Exclusion Criteria:
Contacts and Locations| Contact: Yves Gandon, MD | 33-2-9928-4261 | yves.gandon@chu-rennes.fr |
| Contact: Eric Bellissant, MD, PhD | 33-2-9928-9200 | eric.bellissant@chu-rennes.fr |
| France | |
| Hôpital de Pontchaillou | Recruiting |
| Rennes, France, 35033 | |
| Contact: Yves Gandon, MD 33-2-9928-4261 yves.gandon@chu-rennes.fr | |
| Principal Investigator: Yves Gandon, MD | |
| Sub-Investigator: Fabrice Lainé, MD | |
| Sub-Investigator: Bruno Turlin, MD | |
| Sub-Investigator: Martine Ropert, MD | |
| CHU Angers | Recruiting |
| Angers, France, 49033 | |
| Contact: Christophe Aubé, MD 33-1-4135-4279 ChAube@chu-angers.fr | |
| Principal Investigator: Christophe Aubé, MD | |
| Sub-Investigator: Sophie Michalak, MD | |
| Sub-Investigator: Paul Calès, MD | |
| Sub-Investigator: Frédéric Oberti, MD | |
| Sub-Investigator: Isabelle Fouchard-Hubert, MD | |
| Sub-Investigator: Jérôme Boursier, MD | |
| Hôpital Huriez | Not yet recruiting |
| Lille, France, 59037 | |
| Contact: Olivier Ernst, MD 33-3-2044-6233 oernst@chru-lille.fr | |
| Principal Investigator: Olivier Ernst, MD | |
| Sub-Investigator: Philippe Mathurin, MD | |
| Sub-Investigator: Valérie Canva, MD | |
| Sub-Investigator: Sébastien Dharancy, MD | |
| Sub-Investigator: Emmanuelle Leteurtre, MD | |
| Hôpital Tenon | Not yet recruiting |
| Paris, France, 75970 | |
| Contact: Franck Boudghene, MD 33-1-5601-7269 franck.boudghene@tnn.aphp.fr | |
| Principal Investigator: Franck Boudghene, MD | |
| Sub-Investigator: Patrice Callard, MD | |
| Sub-Investigator: Jean-Didier Grangé, MD | |
| Hôpital Beaujon | Not yet recruiting |
| Clichy, France, 92118 | |
| Contact: Valérie Vilgrain, MD 33-1-4087-5358 valerie.vilgrain@bjn.aphp.fr | |
| Principal Investigator: Valérie Vilgrain, MD | |
| Sub-Investigator: Dominique Cazals, MD | |
| Hôpital du Brabois | Not yet recruiting |
| Vandoeuvre les Nancy, France, 54511 | |
| Contact: Valérie Laurent, MD 33-3-8315-4186 v_croiselaurent@yahoo.fr | |
| Sub-Investigator: Denis Regent, MD | |
| Principal Investigator: Valérie Laurent, MD | |
| Sub-Investigator: Jean-Pierre Bronowicki, MD | |
| Sub-Investigator: François Plénat, MD | |
| Hôpital de la Timone | Not yet recruiting |
| Marseille, France, 13385 | |
| Contact: Philippe Petit, MD 33-4-9138-6797 ppetit@ap-hm.fr | |
| Principal Investigator: Philippe Petit, MD | |
| Sub-Investigator: Jean-François Pelissier, MD | |
| Hôpital Edouard Herriot | Recruiting |
| Lyon, France, 69003 | |
| Contact: Franck Pilleul, MD 33-4-7211-7540 franck.pilleul@chu-lyon.fr | |
| Principal Investigator: Franck Pilleul, MD | |
| Sub-Investigator: Pierre-Jean Valette, MD | |
| Sub-Investigator: Jérôme Dumortier, MD | |
| Sub-Investigator: Jean-Yves Scoazec, MD | |
| Hôpital Saint Eloi | Not yet recruiting |
| Montpellier, France, 34000 | |
| Contact: Benoît Gallix, MD 33-4-6733-7119 b-gallix@chu-montpellier.fr | |
| Principal Investigator: Benoît Gallix, MD | |
| Sub-Investigator: Pierre Baldet, MD | |
| Sub-Investigator: Georges-Philippe Pageaux, MD | |
| Study Director: | Yves Gandon, MD | Rennes University Hospital |
| Study Chair: | Eric Bellissant, MD, PhD | Rennes University Hospital |
More Information
| Responsible Party: | Rennes University Hospital ( Direction of Clinical Research ) |
| Study ID Numbers: | DGS 2006/0197, PHRC/04-08, CIC0203/044 |
| Study First Received: | November 17, 2006 |
| Last Updated: | September 29, 2008 |
| ClinicalTrials.gov Identifier: | NCT00401336 History of Changes |
| Health Authority: | France: Direction Générale de la Santé |
|
Magnetic resonance imaging Hepatic iron Steatosis |
|
Liver Diseases Metabolic Diseases Metabolic Syndrome X Disorders of Environmental Origin Hepatitis, Viral, Human Iron Metabolism Disorders Abdominal Obesity Metabolic Syndrome Hepatitis Virus Diseases Hyperinsulinism Digestive System Diseases Mental Disorders |
Alcoholism Hepatitis B Substance-Related Disorders DNA Virus Infections Alcohol-Related Disorders Insulin Resistance Hepatitis C Iron Overload Glucose Metabolism Disorders Iron Metabolic Disorder |
|
Liver Diseases Flaviviridae Infections Hepatitis, Viral, Human Disorders of Environmental Origin Iron Metabolism Disorders Hepadnaviridae Infections Hyperinsulinism Pathologic Processes Mental Disorders Syndrome Hepatitis B Substance-Related Disorders Alcohol-Related Disorders |
Hepatitis C RNA Virus Infections Metabolic Syndrome X Disease Metabolic Diseases Virus Diseases Hepatitis Digestive System Diseases Alcoholism DNA Virus Infections Iron Overload Insulin Resistance Glucose Metabolism Disorders |
