Ignite Creation Date:
2025-12-24 @ 12:31 PM
Ignite Modification Date:
2026-02-26 @ 11:05 AM
Study NCT ID:
NCT01865461
Status:
COMPLETED
Last Update Posted:
2021-03-11
First Post:
2013-05-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of MRI Sequences in Hepatic Overload
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 706}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-10', 'studyFirstSubmitDate': '2013-05-27', 'studyFirstSubmitQcDate': '2013-05-30', 'lastUpdatePostDateStruct': {'date': '2021-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-05-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the quantification deviations of hepatic iron and fat overloads between the new sequences and the conventional sequences.', 'timeFrame': '18 months', 'description': 'Evaluation of the robustness and the relative accuracy, comparison of sequences currently performed in daily clinical practice, of hepatic iron and fat content quantification with non-invasive new abdominal MRI sequences.'}], 'secondaryOutcomes': [{'measure': 'Analysis of the accuracy of quantification: of the iron concentration against biochemical, semi-quantitative histological or subtracted iron volume compared to the hepatic volume analysis', 'timeFrame': '18 months', 'description': 'Evaluation of the accuracy of these new MRI sequences for hepatic iron and fat quantification, when patients have had in their normal care and management a biopsy or a bleedings subtracted iron volume leading to a desaturation.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Magnetic Resonance Imaging'], 'conditions': ['Iron and Fat Hepatic Overload']}, 'descriptionModule': {'briefSummary': 'MRI, without any contrast injection, allows a non-invasive evaluation and quantification of hepatic overloads, especially iron (liver iron content LIC) and fat (steatosis) overloads, but in certain clinical circumstances, cases require to improve performances. The aim of the study is to add to MRI scans which currently must be performed innovative sequences appropriate for the clinical question to overall appreciate on a varied range of patients their quality, their robustness, their relative performance and, for patients having a biopsy, their accuracy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with or suspected clinically to be with a hepatic overload pathology (hepatic iron and/or fat overload)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women ≥ 18 years of age\n* Patients with or suspected clinically to be with a hepatic overload pathology (hepatic iron and/or fat overload) and who need a diagnostic or pre-therapeutic MRI from his initial management or during his monitoring,\n* Patient able to provide written informed consent and can understand and comply with the requirements of the study\n* Patient having received the information about the protocol and having not expressed his opposition to participate.\n\nExclusion Criteria:\n\nDue to MRI :\n\n* pacemaker or defibrillator,\n* MRI non-compatible heart valve,\n* clips, stents, coils, etc… non-compatible with MRI,\n* cochlear implants,\n* neuronal or peripheric simulator,\n* intra-orbital or encephalic metallic foreign body, foreign body close to eyes, foreign body near the eyes, injury by metallic luster (war, ball),\n* endoprosthesis received since less than 4weeks and osteosynthesis equipment received since less than 6 weeks,\n* claustrophobia,\n* pump, tattoo, permanent make-up, intrauterine device, patch,\n* metal, magnetic, non-removable and in the area of the analyse field material\n\nOther criteria :\n\n* unstable hemodynamic state, acute respiratory insufficiency, hemodynamically unstable acute respiratory failure, poor general condition or the necessity of a continuous monitoring incompatible with the MRI constraint,\n* adults legally protected (under judicial protection, guardianship, or supervision), persons deprived of their liberty,\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT01865461', 'acronym': 'HEPAT_MR', 'briefTitle': 'Evaluation of MRI Sequences in Hepatic Overload', 'organization': {'class': 'OTHER', 'fullName': 'Rennes University Hospital'}, 'officialTitle': 'Evaluation of MRI Sequences in Hepatic Overload.', 'orgStudyIdInfo': {'id': '2013-A00197-38'}}, 'contactsLocationsModule': {'locations': [{'zip': '35033', 'city': 'Rennes', 'country': 'France', 'facility': 'Rennes University Hospital', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rennes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}