Iron and Fat Hepatic OverloadHEPAT_MRNCT01865461
Evaluation of MRI Sequences in Hepatic Overload
An observational study of Iron and Fat Hepatic Overload, run by Rennes University Hospital at 1 site in France.
Trial summary
MRI, without any contrast injection, allows a non-invasive evaluation and quantification of hepatic overloads, especially iron (liver iron content LIC) and fat (steatosis) overloads, but in certain clinical circumstances, cases require to improve performances. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron and Fat Hepatic Overload
- How many people
- 706 participants
- Where
- 1 siteFrance
- Study dates
- 4 Mar 2013to 19 Dec 2018
- Phase
- Observational
- 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
Study population: Patients with or suspected clinically to be with a hepatic overload pathology (hepatic iron and/or fat overload)
Who may be able to join
- Men and women ≥ 18 years of age
- Patients with or suspected clinically to be with a hepatic overload pathology (hepatic iron and/or fat overload) and who need a diagnostic or pre-therapeutic MRI from his initial management or during his monitoring,
- Patient able to provide written informed consent and can understand and comply with the requirements of the study
- Patient having received the information about the protocol and having not expressed his opposition to participate.
Who cannot join
- Due to MRI :
- pacemaker or defibrillator,
- MRI non-compatible heart valve,
- clips, stents, coils, etc… non-compatible with MRI,
- cochlear implants,
- neuronal or peripheric simulator,
Show all 15Show fewer
- intra-orbital or encephalic metallic foreign body, foreign body close to eyes, foreign body near the eyes, injury by metallic luster (war, ball),
- endoprosthesis received since less than 4weeks and osteosynthesis equipment received since less than 6 weeks,
- claustrophobia,
- pump, tattoo, permanent make-up, intrauterine device, patch,
- metal, magnetic, non-removable and in the area of the analyse field material
- Other criteria :
- unstable hemodynamic state, acute respiratory insufficiency, hemodynamically unstable acute respiratory failure, poor general condition or the necessity of a continuous monitoring incompatible with the MRI constraint,
- adults legally protected (under judicial protection, guardianship, or supervision), persons deprived of their liberty,
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of MRI Sequences in Hepatic Overload.
MRI, without any contrast injection, allows a non-invasive evaluation and quantification of hepatic overloads, especially iron (liver iron content LIC) and fat (steatosis) overloads, but in certain clinical circumstances, cases require to improve performances. The aim of the study is to add to MRI scans which currently must be performed innovative sequences appropriate for the clinical question to overall appreciate on a varied range of patients their quality, their robustness, their relative performance and, for patients having a biopsy, their accuracy.
- Conditions
- Iron and Fat Hepatic Overload
- Keywords
- Magnetic Resonance Imaging
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the quantification deviations of hepatic iron and fat overloads between the new sequences and the conventional sequences.
Evaluation of the robustness and the relative accuracy, comparison of sequences currently performed in daily clinical practice, of hepatic iron and fat content quantification with non-invasive new abdominal MRI sequences.
Measured: 18 months
Secondary outcomes (1)
Analysis of the accuracy of quantification: of the iron concentration against biochemical, semi-quantitative histological or subtracted iron volume compared to the hepatic volume analysis
Evaluation of the accuracy of these new MRI sequences for hepatic iron and fat quantification, when patients have had in their normal care and management a biopsy or a bleedings subtracted iron volume leading to a desaturation.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2013 (estimated)
- Study start4 Mar 2013
- Primary completion19 Dec 2018
- Study completion19 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron and Fat Hepatic OverloadStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 706 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01865461
- Sponsor's protocol ID
- 2013-A00197-38
- Acronym
- HEPAT_MR
- Status last verified
- Mar 2020
- First submitted
- 27 May 2013
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of MRI Sequences in Hepatic Overload.
- ClinicalTrials.gov ID
- NCT01865461
- Acronym / sponsor ID
- HEPAT_MR / 2013-A00197-38
- Conditions
- Iron and Fat Hepatic Overload
- Keywords
- Magnetic Resonance Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 706 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 4 Mar 2013 (actual)
- Primary completion
- 19 Dec 2018 (actual)
- Study completion
- 19 Dec 2018 (actual)
- First posted
- 31 May 2013 (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.
MRI, without any contrast injection, allows a non-invasive evaluation and quantification of hepatic overloads, especially iron (liver iron content LIC) and fat (steatosis) overloads, but in certain clinical circumstances, cases require to improve performances. The aim of the study is to add to MRI scans which currently must be performed innovative sequences appropriate for the clinical question to overall appreciate on a varied range of patients their quality, their robustness, their relative performance and, for patients having a biopsy, their accuracy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with or suspected clinically to be with a hepatic overload pathology (hepatic iron and/or fat overload)
Key inclusion criteria (4 listed)
- Men and women ≥ 18 years of age
- Patients with or suspected clinically to be with a hepatic overload pathology (hepatic iron and/or fat overload) and who need a diagnostic or pre-therapeutic MRI from his initial management or during his monitoring,
- Patient able to provide written informed consent and can understand and comply with the requirements of the study
- Patient having received the information about the protocol and having not expressed his opposition to participate.
Key exclusion criteria (15 listed)
- pacemaker or defibrillator,
- MRI non-compatible heart valve,
- clips, stents, coils, etc… non-compatible with MRI,
- cochlear implants,
- neuronal or peripheric simulator,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of the quantification deviations of hepatic iron and fat overloads between the new sequences and the conventional sequences.
Time frame: 18 months
Evaluation of the robustness and the relative accuracy, comparison of sequences currently performed in daily clinical practice, of hepatic iron and fat content quantification with non-invasive new abdominal MRI sequences.
1 secondary outcome
Analysis of the accuracy of quantification: of the iron concentration against biochemical, semi-quantitative histological or subtracted iron volume compared to the hepatic volume analysis
Time frame: 18 months
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 11 Mar 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iron and Fat Hepatic Overload, run by Rennes University Hospital at 1 site in France.
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 4 inclusion and 15 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 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Evaluation of the quantification deviations of hepatic iron and fat overloads between the new sequences and the conventional sequences. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Mar 2021; AzTrials last refreshed its copy on 31 Oct 2026.