Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-01-04 @ 4:05 PM
Study NCT ID:
NCT06622967
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-10-02
First Post:
2024-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
KNUCH CadAI-B-1(KCB-1)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-30', 'studyFirstSubmitDate': '2024-09-17', 'studyFirstSubmitQcDate': '2024-09-30', 'lastUpdatePostDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'BeamWorks Usability Evaluation Scale (Score of BeamWorks System Usability Scale (SUS))', 'timeFrame': 'At the end of the trial, up to 6 months', 'description': '12\\~30 : Unacceptable, 30\\~40 :Marginal, \\>40:Acceptable'}], 'primaryOutcomes': [{'measure': 'Lesion and Per-patient Diagnostic Performance', 'timeFrame': 'At the end of the trial, up to 6 months', 'description': 'AUC (Area Under the Curve), Sensitivity, Specificity'}], 'secondaryOutcomes': [{'measure': 'Lesion and Per-patient Detection Performance', 'timeFrame': 'At the end of the trial, up to 6 months', 'description': 'Sensitivity, Specificity'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['breast neoplasm', 'ultrasound'], 'conditions': ['Breast Neoplasm', 'Female']}, 'descriptionModule': {'briefSummary': 'The CadAI-B (Computer Aided Design Artificial Intelligence-Breast) system is a real-time AI diagnostic tool for breast ultrasound. It integrates with ultrasound devices to detect suspicious lesions, providing size, BI-RADS, and malignancy probability. After installation and user training, the system displays real-time breast conditions and automatically analyzes lesions when a freeze frame is set, showing results in seconds. This study will assess CadAI-B\\'s accuracy and reliability by comparing its findings with biopsy results.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'genderBased': True, 'genderDescription': 'Only female', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged 20 years or older\n* Individuals scheduled to undergo breast ultrasound for diagnostic evaluation\n* Patients whose Ground Truth can be determined through biopsy, surgery, or follow-up\n\nExclusion Criteria:\n\n* Images containing artifacts that may affect the interpretation\n* Presence of breast implants\n* Significant breast trauma or mastitis at the time of the breast ultrasound that could cause distortion in image interpretation\n* History of surgery or chemotherapy'}, 'identificationModule': {'nctId': 'NCT06622967', 'briefTitle': 'KNUCH CadAI-B-1(KCB-1)', 'organization': {'class': 'OTHER', 'fullName': 'Kyungpook National University Chilgok Hospital'}, 'officialTitle': 'Multinational Clinical Trial of Real-time Artificial Intelligence System (CadAI-B) for Breast Ultrasound: Prospective Clinical Validation Study', 'orgStudyIdInfo': {'id': 'KNUCH IRB number : 2024-05-026'}, 'secondaryIdInfos': [{'id': 'Digital healthcare demonstrati', 'type': 'OTHER', 'domain': 'Daegu Gyeongbuk Medical Innovation Foundation'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CadAI-B intervention group', 'description': 'Participants in this arm will receive the CadAI-B system for the detection of lesions. The AI-based tool will assist healthcare professionals in identifying lesions through enhanced image analysis.', 'interventionNames': ['Diagnostic Test: CadAI-B']}], 'interventions': [{'name': 'CadAI-B', 'type': 'DIAGNOSTIC_TEST', 'description': 'The ultrasound is performed following the usual process. If there are any lesions or areas of concern identified by the patient, a more detailed analysis is conducted on the affected area.\n\nWhen a lesion is confirmed, the examiner verifies the results through the frozen image, while also securing the results displayed on CadAI-B.\n\nThe examiner uses the analysis from CadAI-B as a reference to make the final BI-RADS classification.\n\nStatic images and cine clips are captured from the most suspicious areas.', 'armGroupLabels': ['CadAI-B intervention group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Daegu', 'country': 'South Korea', 'facility': 'Kyungpook National University Chilgok Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}], 'overallOfficials': [{'name': 'Jeeyeon Lee, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Kyungpook National University Chilgok Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'JeeYeon Lee', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kyungpook National University Chilgok Hospital', 'class': 'OTHER'}, {'name': 'BeamWorks Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'JeeYeon Lee', 'investigatorAffiliation': 'Kyungpook National University Chilgok Hospital'}}}}