Ignite Creation Date:
2025-12-24 @ 11:58 AM
Ignite Modification Date:
2026-02-25 @ 9:46 PM
Study NCT ID:
NCT03746561
Status:
UNKNOWN
Last Update Posted:
2018-11-19
First Post:
2018-11-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Automatic Diagnosis of Spinal Stenosis on CT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013130', 'term': 'Spinal Stenosis'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077321', 'term': 'Deep Learning'}], 'ancestors': [{'id': 'D000069550', 'term': 'Machine Learning'}, {'id': 'D001185', 'term': 'Artificial Intelligence'}, {'id': 'D000465', 'term': 'Algorithms'}, {'id': 'D055641', 'term': 'Mathematical Concepts'}, {'id': 'D016571', 'term': 'Neural Networks, Computer'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2019-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-11-16', 'studyFirstSubmitDate': '2018-11-07', 'studyFirstSubmitQcDate': '2018-11-16', 'lastUpdatePostDateStruct': {'date': '2018-11-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'diagnostic accuracy of deep learning', 'timeFrame': '1 day', 'description': "Diagnostic accuracy of deep learning to determine spinal stenosis compared with radiologists' labels based on CT"}], 'secondaryOutcomes': [{'measure': 'Diagnostic Performance of deep learning', 'timeFrame': '1 day', 'description': "Sensitivity, specificity, positive predictive value and negative predictive value of deep learning compared with radiologists' labels based on CT"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spinal Stenosis']}, 'descriptionModule': {'briefSummary': 'MRI is a common tool for radiographic diagnosis of spinal stenosis, but it is expensive and requires long scanning time. CT is also a useful tool to diagnose spinal stenosis, yet interpretation can be time-consuming with high inter-reader variability even among the most specialized radiologists. In this study, the investigators aim to develop a deep-learning algorithm to automatically detect and classify lumbar spinal stenosis.', 'detailedDescription': 'MRI is a common tool for radiographic diagnosis of spinal stenosis, but it is expensive and requires long scanning time. CT is also a useful tool to diagnose spinal stenosis, yet interpretation can be time-consuming with high inter-reader variability even among the most specialized radiologists. In this study, the investigators aim to develop a deep-learning algorithm to automatically detect and classify lumbar spinal stenosis. It would be a time-saving workflow if the software can assist the radiologists to detect and locate the suspected lesion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Spinal stenosis is a narrowing of the spaces within the spine, which can put pressure on the nerves that travel through the spine. Spinal stenosis occurs most often in the back, the neck, and sometimes the thoracic spine.\n\nSome people with spinal stenosis may not have symptoms. Others may experience pain, tingling, numbness and muscle weakness. Symptoms can worsen over time.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age \\>18 years\n* with radiologists' CT reports on cervical, thoracic and lumbar stenosis\n\nExclusion Criteria:\n\n* not applicable (only specific levels with extensive infections, fractures, tumor, high-grade spondylolisthesis would be excluded for analysis)."}, 'identificationModule': {'nctId': 'NCT03746561', 'acronym': 'ASSIST', 'briefTitle': 'Automatic Diagnosis of Spinal Stenosis on CT', 'organization': {'class': 'OTHER', 'fullName': "Shanghai 10th People's Hospital"}, 'officialTitle': 'Automatic Diagnosis of Spinal Stenosis on CT With Deep Learning', 'orgStudyIdInfo': {'id': 'SHSY181022'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'spinal stenosis', 'description': 'Spinal stenosis is a narrowing of the spaces within your spine, which can put pressure on the nerves that travel through the spine. Spinal stenosis occurs most often in the lower back and the neck.', 'interventionNames': ['Diagnostic Test: deep learning']}], 'interventions': [{'name': 'deep learning', 'type': 'DIAGNOSTIC_TEST', 'description': 'detect and classify spinal stenosis by deep learning', 'armGroupLabels': ['spinal stenosis']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Shisheng He, MD', 'role': 'CONTACT', 'email': 'TJHSS7418@TONGJI.EDU.CN', 'phone': '021-66307580'}, {'name': 'GUOXIN FAN, MD', 'role': 'CONTACT', 'email': 'GFAN@TONGJI.EDU.CN', 'phone': '021-66307580'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Shanghai 10th People's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, {'name': 'Shanghai East Hospital', 'class': 'OTHER'}, {'name': 'Shanghai Tongji Hospital, Tongji University School of Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy Director of Orthopedic Department', 'investigatorFullName': 'Shisheng He, MD', 'investigatorAffiliation': "Shanghai 10th People's Hospital"}}}}