Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:07 AM
Study NCT ID:
NCT04551105
Status:
COMPLETED
Last Update Posted:
2022-11-02
First Post:
2020-09-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evaluation of TaiHao Breast Ultrasound Diagnosis Software
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-02-09', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dcben0@gmail.com', 'phone': '+1 (301) 820-5225', 'title': 'Study Director of Clinical Trials', 'organization': 'Virginia Tech'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events cannot be monitored/assessed. Because this is a retrospective reader study, not a human trial.', 'description': 'This is a retrospective reader study. There is no adverse events and risks.', 'eventGroups': [{'id': 'EG000', 'title': 'First Session: Manual Review First and Then Review With CADx', 'description': 'Each rater will interpret the "Dataset A" cases in different random order without any assistance of artificial assistance first, and then interpret the "Dataset B" cases in different random order with BR-USCAD DS.\n\nReader Group X: Each rater in "Reader Group X" will interpret the "dataset A" cases in different random order without BR-USCAD DS and interpret the "dataset B" cases in different random order with BR-USCAD DS.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'First Session: Review With CADx First and Then Manual Review', 'description': 'Each rater will interpret the "Dataset A" cases in different random order with BR-USCAD DS first, and then interpret the "Dataset B" cases in different random order without any assistance of artificial assistance.\n\nReader Group Y: Each rater in "Reader Group Y" will interpret the "dataset A" cases in different random order with BR-USCAD DS and interpret the "dataset B" cases in different random order without BR-USCAD DS.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Second Session: Manual Review First and Then Review With CADx', 'description': 'At least 4 weeks after first session for memory washing out. Each rater will interpret the "Dataset A" cases in different random order without any assistance of artificial assistance first, and then interpret the "Dataset B" cases in different random order with BR-USCAD DS.\n\nReader Group Y: Each rater in "Reader Group Y" will interpret the "dataset A" cases in different random order with BR-USCAD DS and interpret the "dataset B" cases in different random order without BR-USCAD DS.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Second Session: Review With CADx First and Then Manual Review', 'description': 'At least 4 weeks after first session for memory washing out. Each rater will interpret the "Dataset A" cases in different random order with BR-USCAD DS first, and then interpret the "Dataset B" cases in different random order without any assistance of artificial assistance.\n\nReader Group X: Each rater in "Reader Group X" will interpret the "dataset A" cases in different random order without BR-USCAD DS and interpret the "dataset B" cases in different random order with BR-USCAD DS.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Comparing the Area Under the LROC Curve', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}, {'units': 'case', 'counts': [{'value': '628', 'groupId': 'OG000'}, {'value': '628', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1', 'description': 'read each breast ultrasound case without the BU-CAD decision support assistance referred to as the unaided (or baseline) study'}, {'id': 'OG001', 'title': 'Arm 2', 'description': "read each breast ultrasound case with the aid of BU-CAD decision support referred to as 'aided study"}], 'classes': [{'categories': [{'measurements': [{'value': '0.7786', 'groupId': 'OG000', 'lowerLimit': '0.7463', 'upperLimit': '0.8109'}, {'value': '0.8160', 'groupId': 'OG001', 'lowerLimit': '0.7862', 'upperLimit': '0.8458'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'different in area under the LROC curve', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0374', 'ciLowerLimit': '0.0190', 'ciUpperLimit': '0.0557', 'statisticalMethod': 'OR-DBM model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '10 weeks', 'description': 'The area under the LROC curve (AUC\\_LROC) on the diagnosis of benign and malignant lesions was computed and compared for Aim 1 (baseline) and Arm 2 (with BU-CAD assistance) studies.', 'unitOfMeasure': 'probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'case', 'denomUnitsSelected': 'case', 'populationDescription': 'Of the study breast ultrasound cases, some contained malignant lesions and some contained breast contained benign lesions.'}, {'type': 'SECONDARY', 'title': 'The Reading Time Was Computed and Compared for Aim 1 (Baseline) and Arm 2 (With BU-CAD Assistance) Studies.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}, {'units': 'case', 'counts': [{'value': '628', 'groupId': 'OG000'}, {'value': '628', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1', 'description': "Read each breast ultrasound case without the TaiHao AI assistance referred to as 'the unaided (or baseline) study"}, {'id': 'OG001', 'title': 'Arm 2', 'description': "Read each breast ultrasound case with the aid of BU-CAD decision support referred to as 'aided study'"}], 'classes': [{'categories': [{'measurements': [{'value': '31.75', 'groupId': 'OG000', 'lowerLimit': '11.24', 'upperLimit': '52.25'}, {'value': '18.96', 'groupId': 'OG001', 'lowerLimit': '3.25', 'upperLimit': '34.67'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '12.78', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '10 weeks', 'description': "Each reader's reading time of a case was automatically recorded by the BU-CAD system.\n\nthe average reading times of 16 readers with and without outlier reading times were compared between the aided and unaided sessions using the paired t-test.", 'unitOfMeasure': 'second', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'case', 'denomUnitsSelected': 'case', 'populationDescription': 'Of the study breast ultrasound cases, some contained malignant lesions and some contained breast contained benign lesions.'}, {'type': 'SECONDARY', 'title': 'The Sensitivity, Specificity, PPV, and NPV Were Computed and Compared for Aim 1 (Baseline) and Arm 2 (With BU-CAD Assistance) Studies.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}, {'units': 'case', 'counts': [{'value': '628', 'groupId': 'OG000'}, {'value': '628', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1', 'description': "Read each breast ultrasound case without the TaiHao AI assistance referred to as 'the unaided (or baseline) study"}, {'id': 'OG001', 'title': 'Arm 2', 'description': "Read each breast ultrasound case with the TaiHao AI assistance referred to as 'the aided (or with CAD) study"}], 'classes': [{'title': 'Sensitivity', 'categories': [{'measurements': [{'value': '0.9225', 'groupId': 'OG000', 'lowerLimit': '0.8896', 'upperLimit': '0.9554'}, {'value': '0.9353', 'groupId': 'OG001', 'lowerLimit': '0.9050', 'upperLimit': '0.9655'}]}]}, {'title': 'Specificity', 'categories': [{'measurements': [{'value': '0.3165', 'groupId': 'OG000', 'lowerLimit': '0.2694', 'upperLimit': '0.3636'}, {'value': '0.3611', 'groupId': 'OG001', 'lowerLimit': '0.3124', 'upperLimit': '0.4098'}]}]}, {'title': 'PPV', 'categories': [{'measurements': [{'value': '0.4876', 'groupId': 'OG000', 'lowerLimit': '0.4433', 'upperLimit': '0.5319'}, {'value': '0.5056', 'groupId': 'OG001', 'lowerLimit': '0.4607', 'upperLimit': '0.5505'}]}]}, {'title': 'NPV', 'categories': [{'measurements': [{'value': '0.8623', 'groupId': 'OG000', 'lowerLimit': '0.8048', 'upperLimit': '0.9198'}, {'value': '0.8945', 'groupId': 'OG001', 'lowerLimit': '0.8456', 'upperLimit': '0.9434'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'different in sensitivity', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0013', 'ciLowerLimit': '-0.2307', 'ciUpperLimit': '0.2281', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'different in specificity', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1065', 'ciLowerLimit': '0.0008', 'ciUpperLimit': '0.2122', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'different in PPV', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0860', 'ciLowerLimit': '-0.1824', 'ciUpperLimit': '0.0104', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'different in NPV', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0860', 'ciLowerLimit': '-0.0104', 'ciUpperLimit': '0.1824', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '10 weeks', 'description': "The mean sensitivity, specificity, PPV, and NPV of 16 readers were calculated and compared between the aided and unaided sessions using McNemar's test.", 'unitOfMeasure': 'proportion', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'case', 'denomUnitsSelected': 'case', 'populationDescription': 'Of the study breast ultrasound cases, some contained malignant lesions and some contained breast contained benign lesions.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm 1', 'description': 'Group X readers read group A cases first unaided and then group B cases aided. At least 5 weeks later, group X readers read group B cases unaided, then group A cases aided.'}, {'id': 'FG001', 'title': 'Arm2', 'description': 'Group Y readers read group B cases first unaided and then group A cases aided. At least 5 weeks later, group Y readers read group A cases unaided, then group B cases aided.'}], 'periods': [{'title': 'The 1st Study Sessions', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Each reader of the same groups(8) tudy with the same number of cases (314).', 'groupId': 'FG000', 'numUnits': '314', 'numSubjects': '8'}, {'comment': 'Each reader of the same groups(8) tudy with the same number of cases (314).', 'groupId': 'FG001', 'numUnits': '314', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '314', 'numSubjects': '8'}, {'groupId': 'FG001', 'numUnits': '314', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}]}, {'title': 'The 2st Study Sessions (5 Weeks Later)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Each reader of the same groups(8) tudy with the same number of cases (314).', 'groupId': 'FG000', 'numUnits': '314', 'numSubjects': '8'}, {'comment': 'Each reader of the same groups(8) tudy with the same number of cases (314).', 'groupId': 'FG001', 'numUnits': '314', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '314', 'numSubjects': '8'}, {'groupId': 'FG001', 'numUnits': '314', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'cases', 'recruitmentDetails': 'Six hundred and twenty-eight cases were randomized and split into two groups (A and B) with the same number of cases (314) in each group. Sixteen readers were randomized and split into two groups (X and Y) with the same number of readers (8) in each group.', 'preAssignmentDetails': '628 cases were randomly split into study datasets A and B. Each dataset had 314 cases. For each session, sub-datasets A and B were randomized within the group. Then, a reader read each sub-dataset either unaided or aided by the BU-CAD system.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Without BU-CAD Decision Support Assistance', 'description': 'Group X readers read group A cases(314) first unaided and then group B cases(314) aided. At least 5 weeks later, group X readers read group B cases(314) unaided, then group A cases(314) aided.'}, {'id': 'BG001', 'title': 'With BU-CAD Decision Support Assistance', 'description': 'Group Y readers read group B cases(314) first unaided and then group A cases(314) aided. At least 5 weeks later, group Y readers read group A cases(314) unaided, then group B(314) cases aided.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-02', 'size': 374302, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-04-11T23:59', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-11', 'studyFirstSubmitDate': '2020-09-02', 'resultsFirstSubmitDate': '2022-01-13', 'studyFirstSubmitQcDate': '2020-09-10', 'lastUpdatePostDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-10-11', 'studyFirstPostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparing the Area Under the LROC Curve', 'timeFrame': '10 weeks', 'description': 'The area under the LROC curve (AUC\\_LROC) on the diagnosis of benign and malignant lesions was computed and compared for Aim 1 (baseline) and Arm 2 (with BU-CAD assistance) studies.'}], 'secondaryOutcomes': [{'measure': 'The Reading Time Was Computed and Compared for Aim 1 (Baseline) and Arm 2 (With BU-CAD Assistance) Studies.', 'timeFrame': '10 weeks', 'description': "Each reader's reading time of a case was automatically recorded by the BU-CAD system.\n\nthe average reading times of 16 readers with and without outlier reading times were compared between the aided and unaided sessions using the paired t-test."}, {'measure': 'The Sensitivity, Specificity, PPV, and NPV Were Computed and Compared for Aim 1 (Baseline) and Arm 2 (With BU-CAD Assistance) Studies.', 'timeFrame': '10 weeks', 'description': "The mean sensitivity, specificity, PPV, and NPV of 16 readers were calculated and compared between the aided and unaided sessions using McNemar's test."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Breast Cancer', 'Breast Diseases']}, 'descriptionModule': {'briefSummary': 'The BR-USCAD DS Module is a computer-assisted detection and diagnosis software based on a deep learning algorithm. This retrospective, fully-crossed, multi-reader, multi-case (MRMC) study aims to compare the performances of readers without and with the aid of the Breast Ultrasound Image Reviewed with Assistance of Computer-Assisted Detection and Diagnosis System (BR-USCAD DS) in interpreting breast ultrasound images of lesions.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* B-mode breast ultrasound image\n* Female, age 21 or older\n* Breast lesion images acquired before a biopsy or surgery - these images were retrospectively collected with histology report.\n* Non-biopsied benign lesions with negative follow-up for a minimum of 24 months\n* At least two orthogonal views of a lesion\n\nExclusion Criteria:\n\n* Breast lesion images acquired after biopsy or surgery.\n* Any breast surgeries or interventional procedures in the 12 months prior to ultrasound imaging\n* Case demonstrating administrative or technical errors\n* Multiple lesions in one 2-D ultrasound image\n* Breast ultrasound images with Doppler, elastography, or other overlays present\n* Case with less than 2-year follow-up and without biopsy confirmation'}, 'identificationModule': {'nctId': 'NCT04551105', 'briefTitle': 'Evaluation of TaiHao Breast Ultrasound Diagnosis Software', 'organization': {'class': 'INDUSTRY', 'fullName': 'TaiHao Medical Inc.'}, 'officialTitle': 'Evaluation of TaiHao Breast Ultrasound Diagnosis Software', 'orgStudyIdInfo': {'id': 'TaiHao BR-USCAD VT 20-249'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'First session: manual review first and then review with CADx', 'description': 'Reader Group X interpret the "Dataset A" cases in different random order without any assistance of AI first, and then interpret the "Dataset B" cases in different random order with TaiHao AI system.', 'interventionNames': ['Diagnostic Test: Reader Group X - Session 1']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'First session: review with CADx first and then manual review', 'description': 'Reader Group Y interpret the "Dataset A" cases in different random order with TaiHao AI system first, and then interpret the "Dataset B" cases in different random order without any assistance of AI.', 'interventionNames': ['Diagnostic Test: Reader Group Y - Session 1']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Second session: manual review first and then review with CADx', 'description': 'At least 4 weeks after first session for memory washing out. Reader Group X interpret the "Dataset A" cases in different random order with TaiHao AI system first, and then interpret the "Dataset B" cases in different random order without any assistance of AI.', 'interventionNames': ['Diagnostic Test: Reader Group X - Session 2']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Second session: review with CADx first and then manual review', 'description': 'At least 4 weeks after first session for memory washing out. Rader Group Y interpret the "Dataset A" cases in different random order without any assistance of AI first, and then interpret the "Dataset B" cases in different random order with TaiHao AI system.', 'interventionNames': ['Diagnostic Test: Reader Group Y - Session 2']}], 'interventions': [{'name': 'Reader Group X - Session 1', 'type': 'DIAGNOSTIC_TEST', 'description': 'Each rater in "Reader Group X" will interpret the "dataset A" cases in different random order without BR-USCAD DS and interpret the "dataset B" cases in different random order with BR-USCAD DS.', 'armGroupLabels': ['First session: manual review first and then review with CADx']}, {'name': 'Reader Group Y - Session 1', 'type': 'DIAGNOSTIC_TEST', 'description': 'Each rater in "Reader Group Y" will interpret the "dataset A" cases in different random order with BR-USCAD DS and interpret the "dataset B" cases in different random order without BR-USCAD DS.', 'armGroupLabels': ['First session: review with CADx first and then manual review']}, {'name': 'Reader Group X - Session 2', 'type': 'DIAGNOSTIC_TEST', 'description': 'Each rater in "Reader Group X" will interpret the "dataset A" cases in different random order with BR-USCAD DS and interpret the "dataset B" cases in different random order without BR-USCAD DS.', 'armGroupLabels': ['Second session: manual review first and then review with CADx']}, {'name': 'Reader Group Y - Session 2', 'type': 'DIAGNOSTIC_TEST', 'description': 'Each rater in "Reader Group Y" will interpret the "dataset A" cases in different random order without BR-USCAD DS and interpret the "dataset B" cases in different random order with BR-USCAD DS.', 'armGroupLabels': ['Second session: review with CADx first and then manual review']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22203', 'city': 'Arlington', 'state': 'Virginia', 'country': 'United States', 'facility': 'Arlington Innovation Center: Health Research - Virginia Tech', 'geoPoint': {'lat': 38.88101, 'lon': -77.10428}}], 'overallOfficials': [{'name': 'Shih Chung Lo, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Arlington Innovation Center: Health Research - Virginia Tech'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TaiHao Medical Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Columbia University', 'class': 'OTHER'}, {'name': 'Taipei Veterans General Hospital, Taiwan', 'class': 'OTHER_GOV'}, {'name': 'Virginia Polytechnic Institute and State University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}