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

• Sponsor: Rennes University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00401336
• Collaborator: Ministry of Health, France (Other)
• Enrollment: 250
• Locations: 10
• Arm: 1
• Duration (Months): 76
• Patients Per Site: 25
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Iron Overload; Metabolic Syndrome X; Hepatitis B; Hepatitis C; Alcohol Abuse	Device: Magnetic resonance imaging multiecho gradient-echo sequence	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 250 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Quantification of Liver Iron Overload and Steatosis Using a New Magnetic Resonance Imaging Multiecho Gradient-echo Sequence
• Study Start Date: Nov 1, 2006
• Actual Primary Completion Date: Mar 1, 2013
• Actual Study Completion Date: Mar 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Liver to muscle signal intensity ratio and T2* calculation versus liver iron concentration [during examination]

Secondary Outcome Measures

1. Difference between in-phase and out-phase T2* calculation versus liver fat concentration [during examination]

2. Correlation between biochemical and MRI quantification of liver iron [during examination]

3. Correlation between participating centers [during examination]

4. Reproducibility of the multiecho gradient-echo sequence [during examination]

5. Influence of the antenna for the multiecho gradient-echo sequence [during examination]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• 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

Locations

	Site	City	State	Country	Postal Code
1	CHU Angers	Angers		France	49033
2	Hôpital Beaujon	Clichy		France	92118
3	Hôpital Huriez	Lille		France	59037
4	Hôpital Edouard Herriot	Lyon		France	69003
5	Hôpital de la Timone	Marseille		France	13385
6	Hôpital Saint Eloi	Montpellier		France	34000
7	Hôpital Tenon	Paris		France	75970
8	Hôpital de Pontchaillou	Rennes		France	35033
9	Hôpital du Brabois	Vandoeuvre les Nancy		France	54511
10	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rennes University Hospital
• ClinicalTrials.gov Identifier: NCT00401336
• Other Study ID Numbers: DGS 2006/0197; PHRC/04-08; CIC0203/044
• First Posted: Nov 20, 2006
• Last Update Posted: Mar 8, 2013
• Last Verified: Jul 1, 2012

• Keywords provided by Rennes University Hospital: Magnetic resonance imaging; Hepatic iron; Steatosis
• Additional relevant MeSH terms: Hepatitis A; Hepatitis C; Hepatitis B; Hepatitis; Fatty Liver; Metabolic Syndrome; Iron Overload; Alcoholism

Study Results

No Results Posted as of Mar 8, 2013