Quantification of Liver Iron Overload and Steatosis Using Magnetic Resonance Imaging

Hepatitis C Clinical Trial

— SURFER  

Official title:

Quantification of Liver Iron Overload and Steatosis Using a New Magnetic Resonance Imaging Multiecho Gradient-echo Sequence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00401336
• Other study ID #: DGS 2006/0197
• Secondary ID: PHRC/04-08CIC020
• Status: Completed
• Phase: N/A
• Start date: November 2006
• Est. completion date: March 2013

Study information

• Verified date: May 2023
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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,...).

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcoholism
• Fatty Liver
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis C
• Iron Overload
• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

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

Locations

Country	Name	City	State
France	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
Spain	Hopital Donostia-San Sebastian	San Sebastian

Sponsors (2)

Lead Sponsor	Collaborator
Rennes University Hospital	Ministry of Health, France

Countries where clinical trial is conducted

France,  Spain, 

References & Publications (3)

d'Assignies G, Paisant A, Bardou-Jacquet E, Boulic A, Bannier E, Laine F, Ropert M, Morcet J, Saint-Jalmes H, Gandon Y. Non-invasive measurement of liver iron concentration using 3-Tesla magnetic resonance imaging: validation against biopsy. Eur Radiol. 2 — View Citation

Paisant A, Boulic A, Bardou-Jacquet E, Bannier E, d'Assignies G, Laine F, Turlin B, Gandon Y. Assessment of liver iron overload by 3 T MRI. Abdom Radiol (NY). 2017 Jun;42(6):1713-1720. doi: 10.1007/s00261-017-1077-8. — View Citation

Paisant A, Laine F, Gandon Y, Bardou-Jacquet E. Is room temperature susceptometer really an accurate method to assess hepatocellular iron? J Hepatol. 2017 Dec;67(6):1345-1346. doi: 10.1016/j.jhep.2017.07.021. Epub 2017 Aug 5. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver to muscle signal intensity ratio and T2* calculation versus liver iron concentration		during examination
Secondary	Difference between in-phase and out-phase T2* calculation versus liver fat concentration		during examination
Secondary	Correlation between biochemical and MRI quantification of liver iron		during examination
Secondary	Correlation between participating centers		during examination
Secondary	Reproducibility of the multiecho gradient-echo sequence		during examination
Secondary	Influence of the antenna for the multiecho gradient-echo sequence		during examination