Iron OverloadSURFERNCT00401336
Quantification of Liver Iron Overload and Steatosis Using Magnetic Resonance Imaging
A study testing Magnetic resonance imaging multiecho gradient-echo sequence in people with Iron Overload and Metabolic Syndrome X, run by Rennes University Hospital at 10 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron Overload, Metabolic Syndrome X, Hepatitis B
- What is being tested?
- Magnetic resonance imaging multiecho gradient-echo sequence
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Nov 2006to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Non cooperating patient,
- Patient with dyspnea,
- Patient with contra-indication to MR imaging (pace-maker, heart valve,...).
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
France9 sites
CHU Angers
Angers, 49033
Hôpital Beaujon
Clichy, 92118
Hôpital Huriez
Lille, 59037
Hôpital Edouard Herriot
Lyon, 69003
Hôpital de la Timone
Marseille, 13385
Hôpital Saint Eloi
Montpellier, 34000
Hôpital Tenon
Paris, 75970
Hôpital de Pontchaillou
Rennes, 35033
Hôpital du Brabois
Vandœuvre-lès-Nancy, 54511
About this study
Official title: Quantification of Liver Iron Overload and Steatosis Using a New Magnetic Resonance Imaging Multiecho Gradient-echo Sequence
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.
Read the 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
- Being tested
- Magnetic resonance imaging multiecho gradient-echo sequence
- Keywords
- Magnetic resonance imaging, Hepatic iron, Steatosis
- Medical subject headings
- Iron Overload, Metabolic Syndrome, Hepatitis B, Hepatitis C, Alcoholism, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance imaging multiecho gradient-echo sequenceDevice
Breath-hold gradient echo sequences with a single echo and a new multiple-echo gradient-echo sequence
| Study group | Role | What they receive |
|---|---|---|
| Magnetic Resonance Imaging | Experimental | New magnetic resonance imaging multiecho gradient-echo sequence Receives: Device: Magnetic resonance imaging multiecho gradient-echo sequence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver to muscle signal intensity ratio and T2* calculation versus liver iron concentration
Measured: during examination
Secondary outcomes (5)
Difference between in-phase and out-phase T2* calculation versus liver fat concentration
Measured: during examination
Correlation between biochemical and MRI quantification of liver iron
Measured: during examination
Correlation between participating centers
Measured: during examination
Reproducibility of the multiecho gradient-echo sequence
Measured: during examination
Influence of the antenna for the multiecho gradient-echo sequence
Measured: during examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2006 (estimated)
- Study startNov 2006
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Iron OverloadStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Yves Gandon, MD, Study director, Rennes University HospitalEric Bellissant, MD, PhD, Study chair, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00401336
- Sponsor's protocol ID
- DGS 2006/0197
- Other IDs
- PHRC/04-08, CIC0203/044
- Acronym
- SURFER
- Status last verified
- May 2023
- First submitted
- 17 Nov 2006
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28224171Paisant 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.
PubMed 28789881d'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.
PubMed 29178028
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of Liver Iron Overload and Steatosis Using a New Magnetic Resonance Imaging Multiecho Gradient-echo Sequence
- ClinicalTrials.gov ID
- NCT00401336
- Acronym / sponsor ID
- SURFER / DGS 2006/0197
- Conditions
- Iron Overload, Metabolic Syndrome X, Hepatitis B, Hepatitis C, Alcohol Abuse
- Keywords
- Magnetic resonance imaging, Hepatic iron, Steatosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Nov 2006
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 20 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Magnetic Resonance Imaging | Experimental | Device: Magnetic resonance imaging multiecho gradient-echo sequenceNew magnetic resonance imaging multiecho gradient-echo sequence |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Non cooperating patient,
- Patient with dyspnea,
- Patient with contra-indication to MR imaging (pace-maker, heart valve,...).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic resonance imaging multiecho gradient-echo sequenceBreath-hold gradient echo sequences with a single echo and a new multiple-echo gradient-echo sequence | Device | Magnetic Resonance Imaging |
Primary outcome
Liver to muscle signal intensity ratio and T2* calculation versus liver iron concentration
Time frame: during examination
5 secondary outcomes
Difference between in-phase and out-phase T2* calculation versus liver fat concentration
Time frame: during examination
Correlation between biochemical and MRI quantification of liver iron
Time frame: during examination
Correlation between participating centers
Time frame: during examination
Reproducibility of the multiecho gradient-echo sequence
Time frame: during examination
Influence of the antenna for the multiecho gradient-echo sequence
Time frame: during examination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Results publication: PubMed 28224171Paisant 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 publication: PubMed 28789881Paisant 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 publication: PubMed 29178028d'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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yves Gandon, MD study director
Rennes University Hospital
Eric Bellissant, MD, PhD study chair
Rennes University Hospital
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic resonance imaging multiecho gradient-echo sequence in people with Iron Overload and Metabolic Syndrome X, run by Rennes University Hospital at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver to muscle signal intensity ratio and T2* calculation versus liver iron concentration (time frame: during examination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00401336, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.