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

Fat Hepatic Overload Clinical Trial

— HEMOCOMPARE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03200457
• Other study ID #: 2017-A01291-52
• Status: Completed
• Phase: N/A
• Start date: July 20, 2018
• Est. completion date: August 28, 2020

Study information

• Verified date: February 2022
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: August 28, 2020
• Est. primary completion date: August 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fat Hepatic Overload
• Iron Hepatic Overload

Intervention

Device:
• 1,5 Tesla abdominal MRI
Measurement of the fat and iron
• 3 Tesla abdominal MRI
Measurement of the fat and iron

Locations

Country	Name	City	State
France	Hôpital St Vincent du Groupement des Hôpitaux de l'Institut Catholique de Lille	Lille
France	CHU de Rennes	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study of the agreement of the measurement of the fat and iron obtained by MRI, based on our previous calibrations (MRQuantif software), on two MRI devices.	Bland and Altman method comparing the quantification of iron and liver fat provided by the two MRI devices in the same patient using the MRQuantif software developed by the imaging department of the University Hospital of Rennes : a 1.5 Tesla device; a 3 Tesla device	Day 1
Secondary	Study of the concordance of the estimation of the quantification of the iron and the hepatic fat provided by our method and those of the constructors	Concordance of the estimation of the quantification of the iron and the hepatic fat provided by our method and those of the constructors	Day 1
Secondary	Analysis of the repeatability of the measurement (two acquisitions for each study).	Intraclass correlation coefficients (ICCs) and Bland & Altmann between two acquisitions	Day 1
Secondary	Analysis of the intra or interobserver reproducibility (several analysis for a single acquisition).	Intraclass correlation coefficients (ICCs) and Bland & Altmann between two readers/readings	Day 1