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OpenTrials
Completed

NCT Number: NCT01865461

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rennes University Hospital

Rennes, 35033, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 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

    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.

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study title

Evaluation of MRI Sequences in Hepatic Overload.

Acronym: HEPAT_MR

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
May 31, 2013
Registry last updated
Mar 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.