Comparison of the Variability of Hepatic Load Quantification in Iron and Fat Estimated by MRI at 1.5 and 3 Tesla

NCT ID: NCT03200457

Last Updated: 2022-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-20
• Study Completion Date: 2020-08-28

Brief Summary

The study proposes to compare the results of two examinations at 1.5 and 3 Tesla obtained on the same day on a series of 80 patients.

Detailed Description

Quantification of hepatic iron by MRI is validated at 1.5 Tesla on a small number of subjects with some discrepancies between the two most used techniques (liver to muscle ratio or calculation of the decay rate of the T2 * signal). Since the initial publications at 1.5 Tesla, new technical innovations have emerged which can allow better quantification. Recently, the investigators have applied these innovations to Rennes and have validated (SURFER study) the possibility of making a quantification of iron and fat on two 3 Tesla devices with good results in a single apnea acquisition. But it is not uncommon to have, in a structure, different magnetic field devices, and it is important to ensure that the results are transposable. It is also crucial for multicentre or cohort studies to ensure consistency. It is therefore proposed to compare the results of two examinations at 1.5 and 3 Tesla obtained on the same day on a series of 80 patients.

Conditions

Iron Hepatic Overload; Fat Hepatic Overload

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patients with hepatic iron overload or steatosis

Each patient (80) will have two MRI exams on the same day: one performed in common practice on a 1.5 Tesla device and the other on a 3 Tesla device.

Group Type: EXPERIMENTAL

1,5 Tesla abdominal MRI

Intervention Type: DEVICE

Measurement of the fat and iron

3 Tesla abdominal MRI

Intervention Type: DEVICE

Measurement of the fat and iron

Interventions

1,5 Tesla abdominal MRI

Measurement of the fat and iron

Intervention Type: DEVICE

3 Tesla abdominal MRI

Measurement of the fat and iron

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Adult 18 years of age or older;
• Having an MRI indication of iron and fat quantification;
• Benefiting from social security;
• Having given a free, informed and written consent.

Exclusion Criteria

Related to MRI

• Implantable cardiac pacemaker or defibrillator;
• Non-MRI cardiac valve compatible;
• Clips, stents, coils, etc ... no MRI compatible;
• Cochlear implants;
• Neuronal or peripheral stimulator;
• Foreign bodies metallic intra orbital or encephalic, foreign body close to the eyes, wound by metallic lash (war, ball);
• Endoprostheses placed for less than 4 weeks and osteosynthesis materials placed less than 6 weeks old;
• Claustrophobia;
• Pumps, tattoos, permanent make-up, intrauterine device, patches;
• Metallic, magnetic, non-removable material and close to the analysis field.

Other criteria

• unstable hemodynamic status, acute respiratory failure, general precarious condition or a need for continuous monitoring incompatible with MRI constraints;
• Persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty.
• Known pregnancy, breastfeeding.

• 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

Principal Investigators

Yves Gandon, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Rennes University Hospital

Locations

Hôpital St Vincent du Groupement des Hôpitaux de l'Institut Catholique de Lille

Lille, , France

CHU de Rennes

Rennes, , France

Countries

France

Other Identifiers

2017-A01291-52

Identifier Type: -

Identifier Source: org_study_id