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

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.

Study Overview

• Status: Completed
• Conditions: Iron Hepatic Overload; Fat Hepatic Overload
• Intervention / Treatment: Device: 1,5 Tesla abdominal MRI; Device: 3 Tesla abdominal MRI

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.

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France
    • Hôpital St Vincent du Groupement des Hôpitaux de l'Institut Catholique de Lille
  • Rennes, France, 35033
    • Chu de Rennes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 1,5 Tesla abdominal MRI; Measurement of the fat and iron; Device: 3 Tesla abdominal MRI; Measurement of the fat and iron

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Analysis of the repeatability of the measurement (two acquisitions for each study).	Intraclass correlation coefficients (ICCs) and Bland & Altmann between two acquisitions	Day 1
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

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Principal Investigator: Yves Gandon, MD, PhD, Rennes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2018
• Primary Completion (Actual): August 28, 2020
• Study Completion (Actual): August 28, 2020

Study Registration Dates

• First Submitted: June 22, 2017
• First Submitted That Met QC Criteria: June 26, 2017
• First Posted (Actual): June 27, 2017

Study Record Updates

• Last Update Posted (Actual): February 15, 2022
• Last Update Submitted That Met QC Criteria: February 14, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: MRI; Liver steatosis; Liver iron
• Other Study ID Numbers: 2017-A01291-52

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No