Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2026-03-01 @ 4:13 PM
Study NCT ID:
NCT03200457
Status:
COMPLETED
Last Update Posted:
2022-02-15
First Post:
2017-06-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Variability of Hepatic Load Quantification in Iron and Fat Estimated by MRI at 1.5 and 3 Tesla
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005234', 'term': 'Fatty Liver'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2020-08-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-14', 'studyFirstSubmitDate': '2017-06-22', 'studyFirstSubmitQcDate': '2017-06-26', 'lastUpdatePostDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'description': '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 :\n\n* a 1.5 Tesla device\n* a 3 Tesla device'}], 'secondaryOutcomes': [{'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', 'description': 'Concordance of the estimation of the quantification of the iron and the hepatic fat provided by our method and those of the constructors'}, {'measure': 'Analysis of the repeatability of the measurement (two acquisitions for each study).', 'timeFrame': 'Day 1', 'description': 'Intraclass correlation coefficients (ICCs) and Bland \\& Altmann between two acquisitions'}, {'measure': 'Analysis of the intra or interobserver reproducibility (several analysis for a single acquisition).', 'timeFrame': 'Day 1', 'description': 'Intraclass correlation coefficients (ICCs) and Bland \\& Altmann between two readers/readings'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Liver iron', 'Liver steatosis', 'MRI'], 'conditions': ['Iron Hepatic Overload', 'Fat Hepatic Overload']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult 18 years of age or older;\n* Having an MRI indication of iron and fat quantification;\n* Benefiting from social security;\n* Having given a free, informed and written consent.\n\nExclusion Criteria:\n\nRelated to MRI\n\n* Implantable cardiac pacemaker or defibrillator;\n* Non-MRI cardiac valve compatible;\n* Clips, stents, coils, etc ... no MRI compatible;\n* Cochlear implants;\n* Neuronal or peripheral stimulator;\n* Foreign bodies metallic intra orbital or encephalic, foreign body close to the eyes, wound by metallic lash (war, ball);\n* Endoprostheses placed for less than 4 weeks and osteosynthesis materials placed less than 6 weeks old;\n* Claustrophobia;\n* Pumps, tattoos, permanent make-up, intrauterine device, patches;\n* Metallic, magnetic, non-removable material and close to the analysis field.\n\nOther criteria\n\n* unstable hemodynamic status, acute respiratory failure, general precarious condition or a need for continuous monitoring incompatible with MRI constraints;\n* Persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty.\n* Known pregnancy, breastfeeding.'}, 'identificationModule': {'nctId': 'NCT03200457', 'acronym': 'HEMOCOMPARE', 'briefTitle': 'Comparison of the Variability of Hepatic Load Quantification in Iron and Fat Estimated by MRI at 1.5 and 3 Tesla', 'organization': {'class': 'OTHER', 'fullName': 'Rennes University Hospital'}, 'officialTitle': 'Comparison of the Variability of Hepatic Load Quantification in Iron and Fat Estimated by MRI at 1.5 and 3 Tesla', 'orgStudyIdInfo': {'id': '2017-A01291-52'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with hepatic iron overload or steatosis', 'description': '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.', 'interventionNames': ['Device: 1,5 Tesla abdominal MRI', 'Device: 3 Tesla abdominal MRI']}], 'interventions': [{'name': '1,5 Tesla abdominal MRI', 'type': 'DEVICE', 'description': 'Measurement of the fat and iron', 'armGroupLabels': ['Patients with hepatic iron overload or steatosis']}, {'name': '3 Tesla abdominal MRI', 'type': 'DEVICE', 'description': 'Measurement of the fat and iron', 'armGroupLabels': ['Patients with hepatic iron overload or steatosis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lille', 'country': 'France', 'facility': "Hôpital St Vincent du Groupement des Hôpitaux de l'Institut Catholique de Lille", 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '35033', 'city': 'Rennes', 'country': 'France', 'facility': 'CHU de Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}], 'overallOfficials': [{'name': 'Yves Gandon, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rennes University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rennes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}