Quantification of Liver Iron Overload and Steatosis Using Magnetic Resonance Imaging

Not Applicable

Completed

• Conditions: Iron Overload; Hepatitis B; Hepatitis C; Metabolic Syndrome X; Alcohol Abuse

• Registration Number: NCT00401336
• Lead Sponsor: Rennes University Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2006-11
• Study First Submitted: 2006-11-17
• Study First Submitted QC: 2006-11-17
• Study First Posted: 2006-11-20
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-22
• Last Update Posted: 2023-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Liver to muscle signal intensity ratio and T2* calculation versus liver iron concentration	during examination

Secondary Outcome Measures

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

Trial Locations

Locations (10)

CHU Angers; 🇫🇷 Angers, France

Hôpital Beaujon; 🇫🇷 Clichy, France

Hôpital Huriez; 🇫🇷 Lille, France

Hôpital Edouard Herriot; 🇫🇷 Lyon, France

Hôpital de la Timone; 🇫🇷 Marseille, France

Hôpital Saint Eloi; 🇫🇷 Montpellier, France

Hôpital Tenon; 🇫🇷 Paris, France

Hôpital de Pontchaillou; 🇫🇷 Rennes, France

Hôpital du Brabois; 🇫🇷 Vandoeuvre les Nancy, France

Hopital Donostia-San Sebastian; 🇪🇸 San Sebastian, Spain