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Completed

NCT Number: NCT03200457

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

1,5 Tesla abdominal MRI

Device

Measurement of the fat and iron

3 Tesla abdominal MRI

Device

Measurement of the fat and iron

Primary outcomes

  1. 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.

    Time frame: Day 1

    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

Secondary outcomes

  1. 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

    Time frame: Day 1

    Concordance of the estimation of the quantification of the iron and the hepatic fat provided by our method and those of the constructors

  2. Analysis of the repeatability of the measurement (two acquisitions for each study).

    Time frame: Day 1

    Intraclass correlation coefficients (ICCs) and Bland & Altmann between two acquisitions

  3. Analysis of the intra or interobserver reproducibility (several analysis for a single acquisition).

    Time frame: Day 1

    Intraclass correlation coefficients (ICCs) and Bland & Altmann between two readers/readings

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Acronym: HEMOCOMPARE

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 27, 2017
Registry last updated
Feb 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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