Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2026-03-02 @ 8:37 PM
Study NCT ID:
NCT02885402
Status:
UNKNOWN
Last Update Posted:
2016-08-31
First Post:
2016-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional Exploration of Cartilage in Patients With Osteoarthritis of the Knee Through MRI Sodium ( 23Na )
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2020-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-08-26', 'studyFirstSubmitDate': '2016-08-26', 'studyFirstSubmitQcDate': '2016-08-26', 'lastUpdatePostDateStruct': {'date': '2016-08-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of sodium released in osteoarthritis patient vs healthy volunteers', 'timeFrame': '24 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': "Osteoarthritis is a degenerative disease of hyaline cartilage not associated with an infection or an inflammatory process that affects millions of people. The first symptoms usually appear from 40-50 years and at this point, conventional radiological tests provide diagnostic elements relatively late, poorly correlated with pain relief and providing no functional information. In this context, there is a real need for imaging techniques for early detection of osteoarthritic changes in a still reversible stage for faster support and MRI appears to be the tool of choice.\n\nConventional proton MRI sequences already allow improved detection possibilities compared to conventional radiology and CT arthrography supplanted. They nevertheless remain insufficient to identify incipient lesions or paradoxically to the point of too advanced lesions. Due to recent technological advances, exploration MRI other nuclei such as sodium is now possible. Quantitation of sodium in the cartilage by sodium MRI allow quantifying proteoglycan loss and ultimately a gradation osteoarthritic reached.\n\nThis project's main objective is to quantify the biochemical changes (sodium content) occurring at different stages of osteoarthritis defined by clinical algofunctional scores (Lequesne) and conventional radiographic scores (Kellgren and Lawrence)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with osteoarthritis\n\nExclusion Criteria:\n\n* patient with contraindication for MRI'}, 'identificationModule': {'nctId': 'NCT02885402', 'briefTitle': 'Functional Exploration of Cartilage in Patients With Osteoarthritis of the Knee Through MRI Sodium ( 23Na )', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique Hopitaux De Marseille'}, 'orgStudyIdInfo': {'id': '2016-05'}, 'secondaryIdInfos': [{'id': '2016-A00427-44', 'type': 'OTHER', 'domain': 'Ansm'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Osteoarthritis patient', 'interventionNames': ['Other: MRI Sodium ( 23Na )']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Healthy volunteers', 'interventionNames': ['Other: MRI Sodium ( 23Na )']}], 'interventions': [{'name': 'MRI Sodium ( 23Na )', 'type': 'OTHER', 'armGroupLabels': ['Healthy volunteers', 'Osteoarthritis patient']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13354', 'city': 'Marseille', 'country': 'France', 'contacts': [{'name': 'Jean Pierre MATTEI, MD', 'role': 'CONTACT', 'email': 'jean-pierre.mattei@ap-hm.fr'}], 'facility': 'Assistance Publique Hopitaux de Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'centralContacts': [{'name': 'Jean Pierre MATTEI, MD', 'role': 'CONTACT', 'email': 'jean-pierre.mattei@ap-hm.fr'}], 'overallOfficials': [{'name': 'Jean-Pierre MATTEI, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique Hopitaux De Marseille'}, {'name': 'Urielle Desalbres', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique Hopitaux De Marseille'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}