Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2025-12-25 @ 7:22 PM
Study NCT ID:
NCT05107232
Status:
RECRUITING
Last Update Posted:
2021-11-12
First Post:
2021-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
OSV-IRM - Volunteer MRI Sequence Optimization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-05', 'studyFirstSubmitDate': '2021-10-06', 'studyFirstSubmitQcDate': '2021-10-31', 'lastUpdatePostDateStruct': {'date': '2021-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of MRI signal', 'timeFrame': '15 days', 'description': 'The quality of the images, maps or signals collected will be compared to standard acquisitions. This evaluation will be done by statistical comparison of visual qualitative criteria by expert radiologists or on quantitative criteria drawn from analyzes computing data obtained by processing experts images (signal-to-noise ratio, contrast-to-noise ratio, blur level, mutual information, co-location of regions highlighted by different techniques, etc.).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['MRI']}, 'descriptionModule': {'briefSummary': 'Optimization of magnetic resonance imaging (MRI) protocols on healthy volunteers and voluntary patients.\n\nIn MRI, a large number of technical parameters (sequence, parameters in sequence, antenna, reconstruction method, etc.) can be changed to optimize the diagnostic quality of the exam. Some optimizations can be performed on participants healthy volunteers, others need to be carried out on images pathological and acquired in voluntary patients.', 'detailedDescription': 'An inclusion visit is planned to verify the criteria for selection, then an imaging visit to perform the MRI examination.\n\nThe imaging visit can take place at the end of the inclusion visit and until the following 15 days. For healthy volunteers, the visits are organized according to their availability. For patients, on the other hand, participation in the research will depend on the programming of the MRI within the framework care.\n\nThis is a single-center prospective study carried out at two sites in the Rennes University Hospital.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Criteria common to all participants:\n\n * Minor or major subject\n * Affiliated, himself or through his parents if he is a minor, to a a social security scheme\n * Having given their free, informed and written consent, and/or which the free, informed and written consent of the holder(s) parental authority has been obtained for minors\n\nSpecific criteria for healthy volunteers:\n\no No medical or surgical history related to the anatomical area(s) scanned\n\nSpecific criteria for voluntary patients:\n\no Indication for an MRI exam as part of its management\n\nExclusion Criteria:\n\n* \\- Contraindication to an MRI (pacemaker or pacemaker, neurostimulator, intra-orbital metal body, vascular clip ferromagnetic)\n* Pregnancy\n* Legal protection measure for adults in progress (safeguard of justice, guardianship, curatorship) or subject deprived of liberty'}, 'identificationModule': {'nctId': 'NCT05107232', 'acronym': 'OSV-IRM', 'briefTitle': 'OSV-IRM - Volunteer MRI Sequence Optimization', 'organization': {'class': 'OTHER', 'fullName': 'Rennes University Hospital'}, 'officialTitle': 'OSV-IRM - Volunteer MRI Sequence Optimization', 'orgStudyIdInfo': {'id': '35RC21_8958_OSV-IRM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Participants', 'description': 'Patients and Healthy volunteers included will have an MRI', 'interventionNames': ['Other: MRI']}], 'interventions': [{'name': 'MRI', 'type': 'OTHER', 'description': 'MRI', 'armGroupLabels': ['Participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35000', 'city': 'Rennes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Blandine Gautier', 'role': 'CONTACT'}, {'name': 'Jean-Christophe Ferre, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}], 'centralContacts': [{'name': 'Blandine Gautier', 'role': 'CONTACT', 'email': 'blandine.gautier@chu-rennes.fr', 'phone': '299282591', 'phoneExt': '+33'}, {'name': 'Jean-Christophe Ferre, Pr', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Jean-Christophe FERRE, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Rennes'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rennes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}