Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2026-02-06 @ 9:02 PM
Study NCT ID:
NCT05744102
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-02-24
First Post:
2023-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improve MRI Diagnosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2016}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-03-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2030-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-15', 'studyFirstSubmitDate': '2023-01-23', 'studyFirstSubmitQcDate': '2023-02-15', 'lastUpdatePostDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Image quality', 'timeFrame': '7 years', 'description': 'The main evaluation criterion will be the choice of the two (or three) evaluators as to the best sequence between the new sequence and the standard sequence.'}], 'secondaryOutcomes': [{'measure': 'Acquisition period', 'timeFrame': '7 years', 'description': 'Average acquisition time'}, {'measure': 'Apnea', 'timeFrame': '7 years', 'description': 'Proportion of patients for whom apnea was requested.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Advanced MRI'], 'conditions': ['New MRI Techniques']}, 'descriptionModule': {'briefSummary': 'The main objective of the research is to compare by two blind evaluators new MRI techniques with routinely used sequences.', 'detailedDescription': '"The main evaluation criterion will be the choice of the two (or three) evaluators as to the best sequence between the new sequence and the standard sequence.\n\nThe decision criterion for considering a new sequence as superior to the standard sequence will be based on two measures:\n\n1. The proportion of patients for whom the new sequence was preferred, which must be greater than or equal to 75%;\n2. Inter-observer agreement (Cohen\'s Kappa coefficient), which must be greater than or equal to 0.8; When these two criteria are met, the new sequence will be considered superior to the standard sequence"'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient\n* Patient who signed a consent to participate in the study\n* Affiliated patient or beneficiary of a social security scheme\n* Patient having an MRI scheduled as part of their care pathway\n* Absence of prohibition of participation in another research\n\nExclusion Criteria:\n\n* Patients under guardianship or curators\n* Pregnant or breastfeeding patients\n* Patients responding to a contraindication to performing an MRI\n* Patient under state medical aid (AME)\n* Adult patients protected by law'}, 'identificationModule': {'nctId': 'NCT05744102', 'acronym': 'DIAGIRM', 'briefTitle': 'Improve MRI Diagnosis', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Evaluation of Advanced and New MRI Techniques to Improve Patient Diagnosis', 'orgStudyIdInfo': {'id': 'APHP220840'}, 'secondaryIdInfos': [{'id': '2022-A01358-35', 'type': 'OTHER', 'domain': 'IDRCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Adult patients having MRI planned at Paul Brousse Hospital', 'description': 'Evaluate new MRI sequences on a population of patients undergoing MRI as part of their usual care', 'interventionNames': ['Diagnostic Test: MRI Image']}], 'interventions': [{'name': 'MRI Image', 'type': 'DIAGNOSTIC_TEST', 'description': 'MRI sequences', 'armGroupLabels': ['Adult patients having MRI planned at Paul Brousse Hospital']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94800', 'city': 'Villejuif', 'country': 'France', 'contacts': [{'name': 'LEWIN MAITE, MD, PhD', 'role': 'CONTACT', 'email': 'maite.lewin@aphp.fr', 'phone': '00 (33) 6 11 15 06 17'}], 'facility': 'CHU Paul Brousse', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'centralContacts': [{'name': 'Maïté LEWIN, MD, PHD', 'role': 'CONTACT', 'email': 'maite.lewin@aphp.fr', 'phone': '(33) 06 11 15 06 17'}, {'name': 'Jean-manuel DA-MOTA-FERREIRA, Radiologic Technologist', 'role': 'CONTACT', 'email': "'jean-manuel.da-mota-ferreira@aphp.fr", 'phone': '(33) 01 45 59 35 26'}], 'overallOfficials': [{'name': 'Maïté LEWIN, MD, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'APHP'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}