Clinical trial NCT03200457: Comparison of the Variability of Hepatic Load Quantification in Iron and Fat Estimated by MRI at 1.5 and 3 Tesla
Official title: Comparison of the Variability of Hepatic Load Quantification in Iron and Fat Estimated by MRI at 1.5 and 3 Tesla
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Hepatic Overload
Fat Hepatic Overload
Keywords: Liver iron
Liver steatosis
MRI
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2017-06-27
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: 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.
timeFrame: Day 1
Secondary outcomes:
measure: 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
timeFrame: Day 1
measure: Analysis of the repeatability of the measurement (two acquisitions for each study).
timeFrame: Day 1
measure: Analysis of the intra or interobserver reproducibility (several analysis for a single acquisition).
timeFrame: Day 1
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital St Vincent du Groupement des Hôpitaux de l'Institut Catholique de Lille
city: Rennes
country: France
facility: CHU de Rennes
Study officials:
affiliation: Rennes University Hospital
name: Yves Gandon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: