Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2026-03-04 @ 8:22 PM
Study NCT ID:
NCT05998720
Status:
UNKNOWN
Last Update Posted:
2023-08-21
First Post:
2023-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Application of New Magnetic Resonance UTE Technique in Hip Joint Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2024-06-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-17', 'studyFirstSubmitDate': '2023-08-02', 'studyFirstSubmitQcDate': '2023-08-17', 'lastUpdatePostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'proton density fat fraction (PDFF)', 'timeFrame': 'Baseline (before surgery)', 'description': 'Magnetic resonance proton density fat fraction'}, {'measure': 'T2 relaxation rate', 'timeFrame': 'Baseline (before surgery)', 'description': 'R2\\*'}, {'measure': 'Magnetization Transfer Ratio (MTR)', 'timeFrame': 'Baseline (before surgery)', 'description': 'magnetization transfer ratio'}, {'measure': 'T1rho', 'timeFrame': 'Baseline (before surgery)', 'description': 'spin-lattice relaxation in the rotation ame'}], 'secondaryOutcomes': [{'measure': 'Subjective rating values', 'timeFrame': 'Baseline (before surgery)', 'description': 'rating values'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hip Disease']}, 'descriptionModule': {'briefSummary': 'Explore the imaging and quantitative monitoring of hip bone, cartilage and ligament by magnetic resonance UTE technology, combined with QCT and DXA technology, to provide a more accurate basis for clinical evaluation and treatment.', 'detailedDescription': "Osteoporosis is a systemic bone metabolism-related disease characterized by decreased bone mass per unit volume, increased bone fragility, decreased bone density, thinning of the bone cortex and changes in bone microstructure. It often occurs in the lumbar spine and hip joint. Femoral neck fracture is a common complication of hip osteoporosis, which seriously affects people's quality of life. UTE technology can clearly image and quantify human cortical bone and cancellous bone, and advanced UTE technology such as STAIR-UTE and UTE-MT have made some progress in the field of osteoporosis. The purpose of this study was to explore UTE technology for imaging and quantitative study of cortical bone, cancellous bone and cartilage of hip joint, and to find more accurate imaging methods for clinical evaluation of hip osteoporosis and other diseases."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who meet the inclusion criteria', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with past or suspected osteoporosis and bone loss;\n2. Patients with previous femoral neck fracture;\n3. Patients with avascular necrosis of femoral head;\n4. Hip osteoarthritis patients.\n\nExclusion Criteria:\n\n1. Patients with metal implants in corresponding parts;\n2. Claustrophobic.'}, 'identificationModule': {'nctId': 'NCT05998720', 'briefTitle': 'Application of New Magnetic Resonance UTE Technique in Hip Joint Lesions', 'organization': {'class': 'OTHER', 'fullName': 'Fifth Affiliated Hospital, Sun Yat-Sen University'}, 'officialTitle': 'Application of New Magnetic Resonance Technique-UTE in Hip Joint Lesions', 'orgStudyIdInfo': {'id': 'ZDWY.FSK.025'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'normal group', 'description': 'There are no lesions on the hip.'}, {'label': 'abnormal group', 'description': 'There are some lesions on the hip.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '519000', 'city': 'Zhuhai', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaojun Chen', 'role': 'CONTACT', 'email': '422175400@qq.com', 'phone': '+8615820587112'}], 'facility': 'Radiography department', 'geoPoint': {'lat': 22.27694, 'lon': 113.56778}}], 'centralContacts': [{'name': 'Xiaojun Chen', 'role': 'CONTACT', 'email': '422175400@qq.com', 'phone': '+8615820587112'}], 'overallOfficials': [{'name': 'Shaolin Li', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Fifth Affiliated Hospital, Sun Yat-Sen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fifth Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}