Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2026-02-01 @ 11:25 PM
Study NCT ID:
NCT03876392
Status:
UNKNOWN
Last Update Posted:
2021-08-12
First Post:
2019-03-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Detection of Bone Marrow Metastases With Magnetic Resonance Imaging
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': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-09', 'studyFirstSubmitDate': '2019-03-04', 'studyFirstSubmitQcDate': '2019-03-13', 'lastUpdatePostDateStruct': {'date': '2021-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sensitivity', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'With bone marrow biopsy as the gold standard, the sensitivity of functional MRI in the diagnosis of bone marrow metastasis'}, {'measure': 'specificity', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'With bone marrow biopsy as the gold standard, the specificity of functional MRI in the diagnosis of bone marrow metastasis'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bone Marrow Metastases', 'Magnetic Resonance Imaging']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to study the value and feasibility of magnetic resonance imaging in detection of bone marrow metastases', 'detailedDescription': 'The patient was diagnosed as bone metastasis by pathology. CT showed no bone marrow biopsy site metastasis (anterior iliac spine or posterior iliac spine). After functional magnetic resonance examination, bone marrow biopsy was performed. Functional magnetic resonance imaging includes conventional SE sequence, T2W SPAIR, e-THRIVE,DWI,IVIM. With bone marrow biopsy as the gold standard, the sensitivity, specificity and coincidence rate of functional MRI in the diagnosis of bone marrow metastasis were evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with malignant tumors (solid tumors or hematological malignancies) were definitely diagnosed by pathology or cytology.\n2. patients with bone metastases confirmed by more than two imaging examinations.\n3. Age 18-75.\n4. ECOG score: 0-2.\n5. The expected survival time is more than 3 months.\n6. Sign the informed consent.\n\nExclusion Criteria:\n\n1. Imaging findings suggest that bone metastases are present at the bone marrow puncture site.\n2. The patient refused bone marrow puncture.\n3. Puncture site with infection.\n4. Severe coagulation dysfunction.\n5. There are implanted instruments in the body, so magnetic resonance imaging can not be performed.'}, 'identificationModule': {'nctId': 'NCT03876392', 'briefTitle': 'Detection of Bone Marrow Metastases With Magnetic Resonance Imaging', 'organization': {'class': 'OTHER', 'fullName': "Shanghai 6th People's Hospital"}, 'officialTitle': 'Detection of Bone Marrow Metastases With Magnetic Resonance Imaging', 'orgStudyIdInfo': {'id': 'MRI001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'magnetic resonance imaging', 'description': 'Detection of bone marrow metastases with magnetic resonance imaging', 'interventionNames': ['Diagnostic Test: magnetic resonance imaging']}], 'interventions': [{'name': 'magnetic resonance imaging', 'type': 'DIAGNOSTIC_TEST', 'description': 'Compare bone marrow biopsy with magnetic resonance imaging to detect bone marrow metastases', 'armGroupLabels': ['magnetic resonance imaging']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200233', 'city': 'Shanghai', 'state': 'Other (Non U.s.)', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'hui zhao, phD', 'role': 'CONTACT', 'email': 'ivy25502@hotmail.com', 'phone': '1'}], 'facility': "Shanghai Sixth People'S Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Shanghai 6th People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Zhao Hui', 'investigatorAffiliation': "Shanghai 6th People's Hospital"}}}}