Evaluation of MRI Sequences in Hepatic Overload

NCT ID: NCT01865461

Last Updated: 2021-03-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 706 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-03-04
• Study Completion Date: 2018-12-19

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.

Conditions

Iron and Fat Hepatic Overload

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rennes University Hospital

Rennes, , France

Countries

France

Other Identifiers

2013-A00197-38

Identifier Type: -

Identifier Source: org_study_id