Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2026-03-15 @ 8:19 AM
Study NCT ID:
NCT06597968
Status:
RECRUITING
Last Update Posted:
2025-07-02
First Post:
2024-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Real World Performance of an AI Based Lung Nodule Detection Tool
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': 45991}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-27', 'studyFirstSubmitDate': '2024-09-12', 'studyFirstSubmitQcDate': '2024-09-12', 'lastUpdatePostDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of patients with actionable lung nodule as measured by CT scan', 'timeFrame': 'up to one year'}, {'measure': 'total number of patients having chest x-ray', 'timeFrame': 'up to one year'}, {'measure': 'number of patients with high risk lung nodule as measured by CT scan', 'timeFrame': 'up to one year'}, {'measure': 'total number of patients referred for a CT scan', 'timeFrame': 'up to one year'}, {'measure': 'number of lung nodule positive images', 'timeFrame': 'up to one year'}, {'measure': 'number of lung nodule negative images', 'timeFrame': 'up to one year'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chest x-ray', 'CAD software'], 'conditions': ['Lung Nodule']}, 'descriptionModule': {'briefSummary': 'chest x-rays will be analyzed by AI software for a secondary read of lung nodules. Chest x-rays will either be sent to the AI tool to be read or to radiologists to read. If the image is sent to the AI tool, the AI software will generate a report on if it detects a lung nodule or not. The image will then be sent to a radiologist to determine if there is agreement or disagreement with the AI tool.', 'detailedDescription': 'The study is a prospective study for measuring the performance of an AI software in detecting lung nodules from chest X-rays. Data collected during the study will be analyzed for study purposes after end date of data collection.\n\nThere will be two study arms: the control arm and the interventional arm.\n\nControl Arm:\n\nThere will be no interruption to the existing standard of care pathway.\n\nInterventional Arm:\n\nUse of AI will occur in parallel to the standard of care pathway.\n\nConsistent with the control Arm, the radiologists or clinicians interpreting the chest x-ray images will proceed as usual based on the existing standard operating procedures of the study site. In addition, the AI software will function as a second reader; meaning images will be processed by the AI software which will generate a report.\n\nIn the event that the radiologist and the AI tool do not agree, cases will be reviewed by qualified study team members twice per week.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Chest x-rays collected on patients aged 18-89', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chest X-ray images of patients aged 18 - 89 years.\n* Modality: CR/DR/DX.\n* PA/view\n* Lung nodules measuring 6 mm -30 mm (for chest X-ray images where presence of nodules is required).\n\nExclusion Criteria:\n\n* Incomplete view of the chest.\n* Lateral view\n* Known lung cancer at the time of Chest x-ray images.'}, 'identificationModule': {'nctId': 'NCT06597968', 'briefTitle': 'Evaluating the Real World Performance of an AI Based Lung Nodule Detection Tool', 'organization': {'class': 'OTHER', 'fullName': 'University Hospitals Cleveland Medical Center'}, 'officialTitle': 'Performance Estimation of Triaging Artificial Intelligence Based Computer-Aided Detection Algorithm in Routine Chest Radiography', 'orgStudyIdInfo': {'id': 'STUDY20240362'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Image going through AI tool', 'description': 'these are the images going through the AI tool', 'interventionNames': ['Device: AI Based CAD Software (qXR-Ln)']}, {'label': 'image not going through AI tool', 'description': 'these are the images not going through the AI tool'}], 'interventions': [{'name': 'AI Based CAD Software (qXR-Ln)', 'type': 'DEVICE', 'description': 'All x-ray images have already been obtained and will then be run through CAD software for secondary nodule detection', 'armGroupLabels': ['Image going through AI tool']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lauren Hahn', 'role': 'CONTACT', 'email': 'Lauren.hahn@uhhospitals.org', 'phone': '216-844-9312'}], 'facility': 'University Hospitals', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'centralContacts': [{'name': 'Lauren Hahn', 'role': 'CONTACT', 'email': 'Lauren.hahn@uhhospitals.org', 'phone': '216-844-9312'}], 'overallOfficials': [{'name': 'Amit Gupta, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals Cleveland Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospitals Cleveland Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Department of Radiology, School of Medicine Member, Cancer Imaging Program, Case Comprehensive Cancer Center, Cardiothoracic Division Chief department of Radiology', 'investigatorFullName': 'Amit Gupta, MD', 'investigatorAffiliation': 'University Hospitals Cleveland Medical Center'}}}}