Clinical trial NCT00401336: Quantification of Liver Iron Overload and Steatosis Using Magnetic Resonance Imaging
Official title: Quantification of Liver Iron Overload and Steatosis Using a New Magnetic Resonance Imaging Multiecho Gradient-echo Sequence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Overload
Metabolic Syndrome X
Hepatitis B
Hepatitis C
Alcohol Abuse
Keywords: Magnetic resonance imaging
Hepatic iron
Steatosis
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2006-11-20
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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,...).

Primary outcomes:
measure: Liver to muscle signal intensity ratio and T2* calculation versus liver iron concentration
timeFrame: during examination
Secondary outcomes:
measure: Difference between in-phase and out-phase T2* calculation versus liver fat concentration
timeFrame: during examination
measure: Correlation between biochemical and MRI quantification of liver iron
timeFrame: during examination
measure: Correlation between participating centers
timeFrame: during examination
measure: Reproducibility of the multiecho gradient-echo sequence
timeFrame: during examination
measure: Influence of the antenna for the multiecho gradient-echo sequence
timeFrame: during examination
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: Clichy
country: France
facility: Hôpital Beaujon
city: Lille
country: France
facility: Hôpital Huriez
city: Lyon
country: France
facility: Hôpital Edouard Herriot
city: Marseille
country: France
facility: Hôpital de la Timone
city: Montpellier
country: France
facility: Hôpital Saint Eloi
city: Paris
country: France
facility: Hôpital Tenon
city: Rennes
country: France
facility: Hôpital de Pontchaillou
city: Vandoeuvre les Nancy
country: France
facility: Hôpital du Brabois
city: San Sebastian
country: Spain
facility: Hopital Donostia-San Sebastian
Study officials:
affiliation: Rennes University Hospital
name: Yves Gandon, MD
role: STUDY_DIRECTOR
affiliation: Rennes University Hospital
name: Eric Bellissant, MD, PhD
role: STUDY_CHAIR
References:
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.
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.
citation: 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.