Quantification of Liver Iron Overload and Steatosis Using Magnetic Resonance Imaging

NCT ID: NCT00401336

Last Updated: 2023-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2013-03-31

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.

Conditions

Iron Overload; Metabolic Syndrome X; Hepatitis B; Hepatitis C; Alcohol Abuse

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Magnetic Resonance Imaging

New magnetic resonance imaging multiecho gradient-echo sequence

Group Type: EXPERIMENTAL

Magnetic resonance imaging multiecho gradient-echo sequence

Intervention Type: DEVICE

Breath-hold gradient echo sequences with a single echo and a new multiple-echo gradient-echo sequence

Interventions

Magnetic resonance imaging multiecho gradient-echo sequence

Breath-hold gradient echo sequences with a single echo and a new multiple-echo gradient-echo sequence

Intervention Type: DEVICE

Eligibility Criteria

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,...).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, France

OTHER_GOV

Sponsor Role: collaborator

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yves Gandon, MD

Role: STUDY_DIRECTOR

Rennes University Hospital

Eric Bellissant, MD, PhD

Role: STUDY_CHAIR

Rennes University Hospital

Locations

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

Vandœuvre-lès-Nancy, , France

Hopital Donostia-San Sebastian

Donostia / San Sebastian, , Spain

Countries

France; Spain

References

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.

Reference Type: RESULT

PMID: 28224171 (View on PubMed)

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.

Reference Type: RESULT

PMID: 28789881 (View on PubMed)

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. 2018 May;28(5):2022-2030. doi: 10.1007/s00330-017-5106-3. Epub 2017 Nov 24.

Reference Type: RESULT

PMID: 29178028 (View on PubMed)

Other Identifiers

PHRC/04-08

Identifier Type: -

Identifier Source: secondary_id

CIC0203/044

Identifier Type: -

Identifier Source: secondary_id

DGS 2006/0197

Identifier Type: -

Identifier Source: org_study_id