Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:48 PM
Study NCT ID:
NCT05156567
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2021-12-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Validation of a Multitask Deep Learning System at Spine Metastasis CT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 280}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-02', 'studyFirstSubmitDate': '2021-12-12', 'studyFirstSubmitQcDate': '2021-12-12', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC', 'timeFrame': '1 months', 'description': 'Area under the receiver operating characteristic curve (AUC) of spinal instability detection'}], 'secondaryOutcomes': [{'measure': 'sensitivity', 'timeFrame': '1 months', 'description': 'sensitivity of spinal instability detection'}, {'measure': 'specificity', 'timeFrame': '1 months', 'description': 'specificity of spinal instability detection'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['To Evaluate Performance of the DLS']}, 'descriptionModule': {'briefSummary': '15 resident oncologists were conducted to evaluate the clinical efficacy of DLS in multicenter. They were 1:1 randomly asked to independently read the test images without the assistance of DLS software or with the assistance. Area under the receiver operating characteristic curve (AUC), sensitivity, and specificity of the DLS were calculated with professional graders as the reference standard.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Spine Metastasis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. pathology-proven diagnosis of solid tumor;\n2. spinal CT scan indicating spinal metastasis with at least one lesion;\n3. no previous surgery for spinal metastasis\n\nExclusion Criteria:\n\n1. spinal CT scans with no sagittal reconstruction;\n2. the radiologist considered that the quality of CT image was unqualified.'}, 'identificationModule': {'nctId': 'NCT05156567', 'briefTitle': 'Validation of a Multitask Deep Learning System at Spine Metastasis CT', 'organization': {'class': 'OTHER', 'fullName': "Shanghai 6th People's Hospital"}, 'officialTitle': 'Multicenter Validation of a Multitask Deep Learning System for Spine Metastases Detection Andfeatures Evaluations at Spine Metastasis CT', 'orgStudyIdInfo': {'id': 'DLS01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'routine physicians'}, {'label': 'DLS', 'interventionNames': ['Diagnostic Test: Deep Learning System']}], 'interventions': [{'name': 'Deep Learning System', 'type': 'DIAGNOSTIC_TEST', 'description': 'The multitask DLS with five algorithms detecting spine metastases and evaluate features (bone lesion quality, posterolateral involvement, and vertebral body collapse)', 'armGroupLabels': ['DLS']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'country': 'China', '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': 'Dr', 'investigatorFullName': 'Zhao Hui', 'investigatorAffiliation': "Shanghai 6th People's Hospital"}}}}