Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2025-12-28 @ 1:54 PM
Study NCT ID:
NCT01058161
Status:
COMPLETED
Last Update Posted:
2014-08-28
First Post:
2010-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High-Field MRI Characterization of Wrist and Hand Cartilage Abnormalities in Inflammatory and Chronic Rheumatisms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}], 'ancestors': [{'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-27', 'studyFirstSubmitDate': '2010-01-27', 'studyFirstSubmitQcDate': '2010-01-27', 'lastUpdatePostDateStruct': {'date': '2014-08-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'can be obtained, one could expect an early detection of joint abnormalities', 'timeFrame': '24 months'}], 'secondaryOutcomes': [{'measure': 'will be to develop a quantitative analyse of the corresponding high-resolution images.', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['wrist and hand cartilage abnormalities in inflammatory and chronic rheumatisms'], 'conditions': ['Abnormality', 'Inflammation', 'Rheumatism']}, 'descriptionModule': {'briefSummary': 'The present project aims at evaluating the diagnostic potential of high-field MRI (3 Teslas) for joint disease. At this field, given that isotropic image resolution of 400 microns can be obtained, one could expect an early detection of joint abnormalities. The additional aim of this project will be to develop a quantitative analyse of the corresponding high-resolution images.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* gp Suspects or affected by rheumatoid polyarthritis\n\n 1. Morning articular Stiffness of at least 15 minutes.\n 2. Arthalgias or Arthritises of at least three joints(articulations), among which those of the hand.\n 3. Possible rheumatoid Presence of a factor(mailman) and\\\\or Antibody anti peptides positive citrullinés.\n 4. Typical possible radiological Hurts on the standard clichés(pictures) of the reached(affected) joints(articulations).\n* gp Affected by stiffening spondylitis with axial and peripheral infringement :\n\n . Lumbago and steepness lumbar vertebra inflammatory. 2. Arthralgias and\\\\or peripheral arthritises 3. Possible presence of an allèle HLA 4. Possible presence of a sacro-illite 5. Absence of the other rheumatic markers\n* gp Affected by connectivity with anti-nuclear antibody positive and / or specific antibodies, suffering of polyarthralgias with or without arthritis\n* gp Healthy control\n* gp Presenting a degenerative osteoarthritis of the wrist traumatic comment, noticed radiologically, which will serve as not inflammatory control.\n\nExclusion Criteria:\n\n* Claustrophobia,\n* metallic foreign bodies,\n* pacemakers The pregnant women,\n* parturients or who breast-feed are excluded from the study'}, 'identificationModule': {'nctId': 'NCT01058161', 'briefTitle': 'High-Field MRI Characterization of Wrist and Hand Cartilage Abnormalities in Inflammatory and Chronic Rheumatisms', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique Hopitaux De Marseille'}, 'officialTitle': 'High-Field MRI Characterization of Wrist and Hand Cartilage Abnormalities in Inflammatory and Chronic Rheumatisms', 'orgStudyIdInfo': {'id': '2009-A01040-57'}, 'secondaryIdInfos': [{'id': '2009 28', 'type': 'OTHER', 'domain': '2009 28'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Suspects or affected by rheumatoid polyarthritis', 'interventionNames': ['Other: high-field MRI (3 Teslas)']}, {'type': 'OTHER', 'label': 'stiffening spondylitis with axial and peripheral infringement', 'interventionNames': ['Other: high-field MRI (3 Teslas)']}, {'type': 'OTHER', 'label': 'polyarthralgies with or without arthritis', 'description': 'Affected by connectivity with anti-nuclear antibody positive and / or specific antibodies, suffering of polyarthralgias with or without arthritis', 'interventionNames': ['Other: high-field MRI (3 Teslas)']}, {'type': 'OTHER', 'label': 'Healthy control', 'interventionNames': ['Other: high-field MRI (3 Teslas)']}, {'type': 'OTHER', 'label': 'not inflammatory control', 'description': 'Presenting a degenerative osteoarthritis of the wrist traumatic comment, noticed radiologically, which will serve as not inflammatory control.', 'interventionNames': ['Other: high-field MRI (3 Teslas)']}], 'interventions': [{'name': 'high-field MRI (3 Teslas)', 'type': 'OTHER', 'description': 'high-field MRI (3 Teslas)', 'armGroupLabels': ['Healthy control', 'Suspects or affected by rheumatoid polyarthritis', 'not inflammatory control', 'polyarthralgies with or without arthritis', 'stiffening spondylitis with axial and peripheral infringement']}, {'name': 'high-field MRI (3 Teslas)', 'type': 'OTHER', 'description': 'high-field MRI (3 Teslas)', 'armGroupLabels': ['stiffening spondylitis with axial and peripheral infringement']}, {'name': 'high-field MRI (3 Teslas)', 'type': 'OTHER', 'description': 'high-field MRI (3 Teslas)', 'armGroupLabels': ['polyarthralgies with or without arthritis']}, {'name': 'high-field MRI (3 Teslas)', 'type': 'OTHER', 'description': 'high-field MRI (3 Teslas)', 'armGroupLabels': ['Healthy control', 'not inflammatory control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Marseille', 'country': 'France', 'facility': 'Assistance Publique Hopitaux de Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'overallOfficials': [{'name': 'sandrine guis, PU PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique Hopitaux De Marseille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}