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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 (HEMOCOMPARE)

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ClinicalTrials.gov Identifier: NCT03200457
Recruitment Status : Recruiting
First Posted : June 27, 2017
Last Update Posted : December 20, 2019
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

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.

Condition or disease Intervention/treatment Phase
Iron Hepatic Overload Fat Hepatic Overload Device: 1,5 Tesla abdominal MRI Device: 3 Tesla abdominal MRI Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Comparison of the Variability of Hepatic Load Quantification in Iron and Fat Estimated by MRI at 1.5 and 3 Tesla
Actual Study Start Date : July 20, 2018
Estimated Primary Completion Date : January 20, 2021
Estimated Study Completion Date : January 20, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03200457


Contacts
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Contact: Yves Gandon, MD, PhD 02.99.28.24.39 yves.gandon@chu-rennes.fr

Locations
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France
Hôpital St Vincent du Groupement des Hôpitaux de l'Institut Catholique de Lille Recruiting
Lille, France
Contact: Paul Borde, MD       Borde.Paul@ghicl.net   
CHU de Rennes Recruiting
Rennes, France, 35033
Contact: Yves Gandon, MD, PhD       yves.gandon@chu-rennes.fr   
Sponsors and Collaborators
Rennes University Hospital
Investigators
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Principal Investigator: Yves Gandon, MD, PhD Rennes University Hospital
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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT03200457    
Other Study ID Numbers: 2017-A01291-52
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: December 20, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rennes University Hospital:
Liver iron
Liver steatosis
MRI