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

Primary Purpose

Iron Overload, Metabolic Syndrome X, Hepatitis B

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Magnetic resonance imaging multiecho gradient-echo sequence
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Iron Overload focused on measuring Magnetic resonance imaging, Hepatic iron, Steatosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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,...).

Sites / Locations

  • CHU Angers
  • Hôpital Beaujon
  • Hôpital Huriez
  • Hôpital Edouard Herriot
  • Hôpital de la Timone
  • Hôpital Saint Eloi
  • Hôpital Tenon
  • Hôpital de Pontchaillou
  • Hôpital du Brabois
  • Hopital Donostia-San Sebastian

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Magnetic Resonance Imaging

Arm Description

New magnetic resonance imaging multiecho gradient-echo sequence

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Difference between in-phase and out-phase T2* calculation versus liver fat concentration
Correlation between biochemical and MRI quantification of liver iron
Correlation between participating centers
Reproducibility of the multiecho gradient-echo sequence
Influence of the antenna for the multiecho gradient-echo sequence

Full Information

First Posted
November 17, 2006
Last Updated
May 22, 2023
Sponsor
Rennes University Hospital
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT00401336
Brief Title
Quantification of Liver Iron Overload and Steatosis Using Magnetic Resonance Imaging
Acronym
SURFER
Official Title
Quantification of Liver Iron Overload and Steatosis Using a New Magnetic Resonance Imaging Multiecho Gradient-echo Sequence
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital
Collaborators
Ministry of Health, France

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Overload, Metabolic Syndrome X, Hepatitis B, Hepatitis C, Alcohol Abuse
Keywords
Magnetic resonance imaging, Hepatic iron, Steatosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Magnetic Resonance Imaging
Arm Type
Experimental
Arm Description
New magnetic resonance imaging multiecho gradient-echo sequence
Intervention Type
Device
Intervention Name(s)
Magnetic resonance imaging multiecho gradient-echo sequence
Intervention Description
Breath-hold gradient echo sequences with a single echo and a new multiple-echo gradient-echo sequence
Primary Outcome Measure Information:
Title
Liver to muscle signal intensity ratio and T2* calculation versus liver iron concentration
Time Frame
during examination
Secondary Outcome Measure Information:
Title
Difference between in-phase and out-phase T2* calculation versus liver fat concentration
Time Frame
during examination
Title
Correlation between biochemical and MRI quantification of liver iron
Time Frame
during examination
Title
Correlation between participating centers
Time Frame
during examination
Title
Reproducibility of the multiecho gradient-echo sequence
Time Frame
during examination
Title
Influence of the antenna for the multiecho gradient-echo sequence
Time Frame
during examination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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,...).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yves Gandon, MD
Organizational Affiliation
Rennes University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Eric Bellissant, MD, PhD
Organizational Affiliation
Rennes University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
CHU Angers
City
Angers
ZIP/Postal Code
49033
Country
France
Facility Name
Hôpital Beaujon
City
Clichy
ZIP/Postal Code
92118
Country
France
Facility Name
Hôpital Huriez
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Hôpital Edouard Herriot
City
Lyon
ZIP/Postal Code
69003
Country
France
Facility Name
Hôpital de la Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Hôpital Saint Eloi
City
Montpellier
ZIP/Postal Code
34000
Country
France
Facility Name
Hôpital Tenon
City
Paris
ZIP/Postal Code
75970
Country
France
Facility Name
Hôpital de Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Hôpital du Brabois
City
Vandoeuvre les Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Hopital Donostia-San Sebastian
City
San Sebastian
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
28224171
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.
Results Reference
result
PubMed Identifier
28789881
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.
Results Reference
result
PubMed Identifier
29178028
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.
Results Reference
result

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Quantification of Liver Iron Overload and Steatosis Using Magnetic Resonance Imaging

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