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Evaluation of MRI Sequences in Hepatic Overload (HEPAT_MR)

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ClinicalTrials.gov Identifier: NCT01865461
Recruitment Status : Recruiting
First Posted : May 31, 2013
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

Brief 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. 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.

Condition or disease
Iron and Fat Hepatic Overload

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Evaluation of MRI Sequences in Hepatic Overload.
Study Start Date : June 2013
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  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 [ Time Frame: 18 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with or suspected clinically to be with a hepatic overload pathology (hepatic iron and/or fat overload)
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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,
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01865461


Locations
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France
Rennes University Hospital Recruiting
Rennes, France, 35033
Contact: Yves Gandon, PU-PH    +33 2.99.28.24.39    yves.gandon@chu-rennes.fr   
Principal Investigator: Yves Gandon, PU-PH         
Sponsors and Collaborators
Rennes University Hospital

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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01865461     History of Changes
Other Study ID Numbers: 2013-A00197-38
First Posted: May 31, 2013    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Keywords provided by Rennes University Hospital:
Magnetic Resonance Imaging