Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-01-01 @ 6:56 PM
Study NCT ID:
NCT05343104
Status:
UNKNOWN
Last Update Posted:
2022-04-25
First Post:
2022-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Osteoarthrosis on 7.0T Magnetic Resonance Imaging
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'}]}, '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2025-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-22', 'studyFirstSubmitDate': '2022-04-19', 'studyFirstSubmitQcDate': '2022-04-22', 'lastUpdatePostDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The thickness of the cartilage of patellar on 7T MRI scan', 'timeFrame': 'baseline', 'description': 'Thickness of different part of the cartilage of patellar measured based on axial PD images'}, {'measure': 'The T2 mapping value of the patellar cartilage on 7T MRI scan', 'timeFrame': 'baseline', 'description': 'T2 relaxation times of the patellar cartilage measured based on T2 mapping'}, {'measure': 'The abnormal signal in the infrapatellar fat pad', 'timeFrame': 'baseline', 'description': 'The exist of abnormal signal in the infrapatellar fat pad detected based on sagittal PD images'}], 'secondaryOutcomes': [{'measure': 'Signal change of the patellar chondral before and after rehabilitation', 'timeFrame': '1 month after rehabilitation', 'description': 'The correlation between abnormal change of the patellar chondral and reaction 1 month after rehabilitation'}, {'measure': 'Signal change of the infrapatellar fat pad before and after rehabilitation', 'timeFrame': '1 month after rehabilitation', 'description': 'The correlation between abnormal signal in the infrapatellar fat pad and reaction 1 month after rehabilitation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MRI', 'Osteoarthrosis'], 'conditions': ['MRI', 'Osteoarthrosis']}, 'descriptionModule': {'briefSummary': 'This clinical trial studies the use of 7-Tesla (7T)and 3T magnetic resonance imaging (MRI) in detecting osteoarthrosis. 7T MRI has increased detection sensitivity, including more accurate lesion delineation, higher inter-rater agreement. Diagnostic procedures such as 7T MRI may help ultimately improved diagnostic and therapies confidence to inform decision making than standard 3T MRI.', 'detailedDescription': '7T MRI increased detection sensitivity, attain superior anatomic resolution, higher spatial and spectral specificity of advanced quantitative techniques, and shorter scan times than 3T MRI. When applied clinically, these benefits translate to increased detection sensitivity, and ultimately improved diagnostic and therapies confidence to inform decision making. This study aim to detect the image characteristics and diagnostic accuracy of osteoarthrosis on 7T MRI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with clinical diagnosis of patellar chondromalacia were continuously included.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age≥18 and ≤80\n* Having no contraindications against MRI\n* Clinically stable\n\nExclusion Criteria:\n\n* Age#18 or #80\n* Pregnancy and other contraindication to MRI scan\n* Informed consent not obtained'}, 'identificationModule': {'nctId': 'NCT05343104', 'briefTitle': 'Osteoarthrosis on 7.0T Magnetic Resonance Imaging', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'Osteoarthrosis on 7.0T Magnetic Resonance Imaging', 'orgStudyIdInfo': {'id': 'Osteoarthrosis-ChinaPLAGH'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Magnetic resonance imaging', 'type': 'DIAGNOSTIC_TEST', 'description': 'Patients recruited will receive Magnetic resonance imaging.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100853', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jiayu Huang, M.S.', 'role': 'CONTACT', 'email': 'huang_jy_cocacola@163.com', 'phone': '+86 17782407581'}], 'facility': 'Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Jiayu Huang, M.S.', 'role': 'CONTACT', 'email': 'huang_jy_cocacola@163.com', 'phone': '+86 17782407581'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director and Clinical Professor', 'investigatorFullName': 'Xin Lou', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}