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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03200457
Acronym
HEMOCOMPARE
Enrollment
92
Registered
2017-06-27
Start date
2018-07-20
Completion date
2020-08-28
Last updated
2022-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fat Hepatic Overload, Iron Hepatic Overload

Keywords

Liver iron, Liver steatosis, MRI

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.

Interventions

DEVICE1,5 Tesla abdominal MRI

Measurement of the fat and iron

DEVICE3 Tesla abdominal MRI

Measurement of the fat and iron

Sponsors

Rennes University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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.Day 1Bland 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

Secondary

MeasureTime frameDescription
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 constructorsDay 1Concordance of the estimation of the quantification of the iron and the hepatic fat provided by our method and those of the constructors
Analysis of the repeatability of the measurement (two acquisitions for each study).Day 1Intraclass correlation coefficients (ICCs) and Bland & Altmann between two acquisitions
Analysis of the intra or interobserver reproducibility (several analysis for a single acquisition).Day 1Intraclass correlation coefficients (ICCs) and Bland & Altmann between two readers/readings

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026