Quantification of Liver Iron Overload and Steatosis Using Magnetic Resonance Imaging

NCT00401336 | Completed

• 3 other identifiers: DGS 2006/0197PHRC/04-08CIC0203/044
• Study Type: interventional
• Target: 250
• Locations: 2 countries
• Sites: 10

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.

Conditions

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

Keywords

Magnetic resonance imaging; Hepatic iron; Steatosis

Outcome Measures

Primary Outcomes (1)

• Liver to muscle signal intensity ratio and T2* calculation versus liver iron concentration

  during examination

Secondary Outcomes (5)

• 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

• Correlation between participating centers

  during examination

• Reproducibility of the multiecho gradient-echo sequence

  during examination

• Influence of the antenna for the multiecho gradient-echo sequence

  during examination

Study Arms (1)

Magnetic Resonance Imaging

EXPERIMENTAL

New magnetic resonance imaging multiecho gradient-echo sequence

Device: Magnetic resonance imaging multiecho gradient-echo sequence

Interventions

Magnetic resonance imaging multiecho gradient-echo sequence DEVICE

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

Magnetic Resonance Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults over 18,
• Having given a written informed consent.

You may not qualify if:

• Non cooperating patient,
• Patient with dyspnea,
• Patient with contra-indication to MR imaging (pace-maker, heart valve,...).

Sponsors & Collaborators

• Rennes University Hospital: lead
• Ministry of Health, France: collaborator

Study Sites (10)

CHU Angers

Angers, 49033, France

Location

Hôpital Beaujon

Clichy, 92118, France

Location

Hôpital Huriez

Lille, 59037, France

Location

Hôpital Edouard Herriot

Lyon, 69003, France

Location

Hôpital de la Timone

Marseille, 13385, France

Location

Hôpital Saint Eloi

Montpellier, 34000, France

Location

Hôpital Tenon

Paris, 75970, France

Location

Hôpital de Pontchaillou

Rennes, 35033, France

Location

Hôpital du Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

Hopital Donostia-San Sebastian

Donostia / San Sebastian, Spain

Location

Related Publications (3)

• 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.

  PMID: 28224171 RESULT

• 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.

  PMID: 28789881 RESULT

• 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.

  PMID: 29178028 RESULT

MeSH Terms

Conditions

Iron Overload; Metabolic Syndrome; Hepatitis B; Hepatitis C; Alcoholism; Fatty Liver

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Flaviviridae Infections; RNA Virus Infections; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Yves Gandon, MD

  Rennes University Hospital

  STUDY DIRECTOR

• Eric Bellissant, MD, PhD

  Rennes University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2006
• First Posted: November 20, 2006
• Study Start: November 1, 2006
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: May 24, 2023

Record last verified: 2023-05

Locations

FR (9); ES (1)