Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2026-02-23 @ 11:57 AM
Study NCT ID:
NCT02643966
Status:
COMPLETED
Last Update Posted:
2023-06-29
First Post:
2015-12-23
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Assessment of Periodic Screening of Women With Denser Breast Using WBUS and DBT
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bergwa@upmc.edu', 'phone': '412-641-1635', 'title': 'Dr. Wendie A. Berg', 'organization': 'University of Pittsburgh'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '3 years', 'eventGroups': [{'id': 'EG000', 'title': 'Whole Breast Ultrasound', 'description': 'All women will receive both 3D mammography and whole breast ultrasound for breast cancer screening; the order of interpretation will vary for each of two radiologists\n\nWhole breast ultrasound: Breast cancer screening with whole breast ultrasound', 'otherNumAtRisk': 6266, 'deathsNumAtRisk': 6266, 'otherNumAffected': 0, 'seriousNumAtRisk': 6266, 'deathsNumAffected': 6, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cancer Yield Per 1,000', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6178', 'groupId': 'OG000'}, {'value': '6178', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Digital Breast Tomosynthesis (DBT)', 'description': 'All women received both 3D mammography (DBT) and whole breast ultrasound (WBUS) for breast cancer screening. This Arm looks at the cancer yield per 1,000 for DBT alone.'}, {'id': 'OG001', 'title': 'DBT and WBUS', 'description': 'All women received both 3D mammography (DBT) and whole breast ultrasound (WBUS) for breast cancer screening. This Arm looks at the cancer yield per 1,000 for DBT+WBUS.'}], 'classes': [{'title': 'Screen 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6178', 'groupId': 'OG000'}, {'value': '6178', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '3.4', 'upperLimit': '7.1'}, {'value': '6.3', 'groupId': 'OG001', 'lowerLimit': '4.5', 'upperLimit': '8.6'}]}]}, {'title': 'Screens 2 & 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5937', 'groupId': 'OG000'}, {'value': '5937', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '5.9'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '4.9', 'upperLimit': '6.9'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'simple proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.3', 'ciLowerLimit': '0.3', 'ciUpperLimit': '2.1', 'pValueComment': 'The threshold for statistical significance was p = 0.05', 'groupDescription': 'The primary unit of analysis was the screening examination. A sample size of 16,700 screens (6,200 women, estimating 8%-10% loss to follow-up each year) was expected to provide 82% power to identify an added cancer detection rate (CDR) from US of 1.1/1,000. Screens were included for analysis if the patient was diagnosed with breast cancer or at least 10.5-month imaging or clinical follow-up (ie, at end of study participation) showed no evidence of breast cancer.', 'statisticalMethod': 'nonparametric bootstrap approach', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'The 95% CIs for differences were estimated using nonparametric bootstrap approach on the basis of 10,000 replicates with women as resampling units', 'nonInferiorityComment': 'We compared DBT cancer yield per 1,000 for first observer (usual care) vs DBT and WBUS cancer yield per 1,000 for first observer for Year/Screen 1.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'simple proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0', 'ciLowerLimit': '0.4', 'ciUpperLimit': '1.5', 'pValueComment': 'The threshold for statistical significance was p = 0.05', 'groupDescription': 'The primary unit of analysis was the screening examination. A sample size of 16,700 screens (6,200 women, estimating 8%-10% loss to follow-up each year) was expected to provide 82% power to identify an added cancer detection rate (CDR) from US of 1.1/1,000. Screens were included for analysis if the patient was diagnosed with breast cancer or at least 10.5-month imaging or clinical follow-up (ie, at end of study participation) showed no evidence of breast cancer.', 'statisticalMethod': 'nonparametric bootstrap approach', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'The 95% CIs for differences were estimated using nonparametric bootstrap approach on the basis of 10,000 replicates with women as resampling units', 'nonInferiorityComment': 'We compared DBT cancer yield per 1,000 for first observer (usual care) vs DBT and WBUS cancer yield per 1,000 for first observer for Years/Screens 2 \\& 3.'}], 'paramType': 'NUMBER', 'timeFrame': '3 Years', 'description': 'Results from the first radiologist observer are presented', 'unitOfMeasure': 'Cancer yield per 1,000', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Screens 2 \\& 3 include women who were analyzable after the end of Screening Round 2'}, {'type': 'PRIMARY', 'title': 'Sensitivity (True Positive Rate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6178', 'groupId': 'OG000'}, {'value': '6178', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Digital Breast Tomosynthesis', 'description': 'All women received both 3D mammography and whole breast ultrasound for breast cancer screening; the order of interpretation varied for each of two radiologists. This Arm looks at the sensitivity of DBT alone for reader 1.'}, {'id': 'OG001', 'title': 'DBT and WBUS', 'description': 'All women received both 3D mammography and whole breast ultrasound for breast cancer screening; the order of interpretation varied for each of two radiologists. This Arm looks at the sensitivity of DBT and WBUS for reader 1.'}], 'classes': [{'title': 'Year/Screen 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '68.9', 'groupId': 'OG000', 'lowerLimit': '53.4', 'upperLimit': '81.8'}, {'value': '86.7', 'groupId': 'OG001', 'lowerLimit': '73.2', 'upperLimit': '95.0'}]}]}, {'title': 'Years/Screens 2 & 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69.1', 'groupId': 'OG000', 'lowerLimit': '57.9', 'upperLimit': '78.9'}, {'value': '82.7', 'groupId': 'OG001', 'lowerLimit': '72.7', 'upperLimit': '90.2'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'simple proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.8', 'ciLowerLimit': '4.4', 'ciUpperLimit': '31.1', 'pValueComment': 'The threshold for statistical significance was p = 0.05', 'groupDescription': 'The primary unit of analysis was the screening examination. A sample size of 16,700 screens (6,200 women, estimating 8%-10% loss to follow-up each year) was expected to provide 82% power to identify an added cancer detection rate (CDR) from US of 1.1/1,000. Screens were included for analysis if the patient was diagnosed with breast cancer or at least 10.5-month imaging or clinical follow-up (ie, at end of study participation) showed no evidence of breast cancer.', 'statisticalMethod': 'nonparametric bootstrap approach', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'The 95% CIs for differences were estimated using nonparametric bootstrap approach on the basis of 10,000 replicates with women as resampling units', 'nonInferiorityComment': 'We compared DBT true positive findings for first observer (usual care) vs DBT and WBUS true positive findings for first observer for Year/Screen 1.'}, {'pValue': '< 0.001', 'groupIds': ['OG000'], 'paramType': 'simple proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.5', 'ciLowerLimit': '4.9', 'ciUpperLimit': '22.3', 'pValueComment': 'The threshold for statistical significance was p = 0.05', 'groupDescription': 'The primary unit of analysis was the screening examination. A sample size of 16,700 screens (6,200 women, estimating 8%-10% loss to follow-up each year) was expected to provide 82% power to identify an added CDR from US of 1.1/1,000.Screens were included for analysis if the patient was diagnosed with breast cancer or at least 10.5-month imaging or clinical follow-up (ie, at end of study participation) showed no evidence of breast cancer.', 'statisticalMethod': 'nonparametric bootstrap approach', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'The 95% CIs for differences were estimated using nonparametric bootstrap approach on the basis of 10,000 replicates with women as resampling units', 'nonInferiorityComment': 'We compared DBT true positive findings for first observer (usual care) vs DBT and WBUS true positive findings for first observer for Years/Screens 2 and 3.'}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': 'DBT true positive findings for first observer (usual care) vs DBT and WBUS true positive findings for first observer', 'unitOfMeasure': 'percentage of participants with cancer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Women diagnosed with cancer'}, {'type': 'SECONDARY', 'title': 'Types of Abnormalities Detected by Ultrasound and Tomosynthesis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17552', 'groupId': 'OG000'}, {'value': '17552', 'groupId': 'OG001'}, {'value': '17552', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Digital Breast Tomosynthesis (DBT)', 'description': 'All women received both 3D mammography (DBT) and whole breast ultrasound (WBUS) for breast cancer screening. This Arm looks at the number of cancers detected by first observer for DBT Alone.'}, {'id': 'OG001', 'title': 'DBT and WBUS', 'description': 'All women received both 3D mammography (DBT) and whole breast ultrasound (WBUS) for breast cancer screening. This Arm looks at the number of cancers detected by first observer for DBT and WBUS.'}, {'id': 'OG002', 'title': 'WBUS Only', 'description': 'All women received both 3D mammography (DBT) and whole breast ultrasound (WBUS) for breast cancer screening. This Arm looks at the number of cancers detected by first observer for WBUS alone.'}], 'classes': [{'title': 'No. of Cancers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17552', 'groupId': 'OG000'}, {'value': '17552', 'groupId': 'OG001'}, {'value': '17552', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}]}, {'title': 'No. of invasive cancers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}]}, {'title': 'No. of Node-positive among available staging', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 years', 'description': 'Counts and percentages of participants diagnosed with cancer and detected by first observer with DBT only, DBT and WBUS, and WBUS only', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Cancers detected by first observer for all 3 Screenings/Years combined'}, {'type': 'PRIMARY', 'title': 'False-positive Recall Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6178', 'groupId': 'OG000'}, {'value': '6178', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Digital Breast Tomosynthesis', 'description': 'All women received both 3D mammography and whole breast ultrasound for breast cancer screening; the order of interpretation varied for each of two radiologists. This Arm looks at the false-positive recall rate of DBT alone for reader 1.'}, {'id': 'OG001', 'title': 'DBT and WBUS', 'description': 'All women received both 3D mammography and whole breast ultrasound for breast cancer screening; the order of interpretation varied for each of two radiologists. This arm looks at the false-positive recall rate of DBT and WBUS for reader 1.'}], 'classes': [{'title': 'Year/Screen 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6133', 'groupId': 'OG000'}, {'value': '6133', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000', 'lowerLimit': '6.4', 'upperLimit': '7.7'}, {'value': '11.5', 'groupId': 'OG001', 'lowerLimit': '10.7', 'upperLimit': '12.3'}]}]}, {'title': 'Years/Screens 2 & 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5856', 'groupId': 'OG000'}, {'value': '5856', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '5.5', 'upperLimit': '6.4'}, {'value': '9.7', 'groupId': 'OG001', 'lowerLimit': '9.1', 'upperLimit': '10.2'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.5', 'ciLowerLimit': '3.8', 'ciUpperLimit': '5.1', 'pValueComment': 'The threshold for statistical significance was p = 0.05', 'statisticalMethod': 'nonparametric bootstrap approach', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'The 95% CIs for differences were estimated using nonparametric bootstrap approach on the basis of 10,000 replicates with women as resampling units', 'nonInferiorityComment': 'We compared DBT false positive findings for first observer (usual care) vs DBT and WBUS false positive findings for first observer for Year/Screen 1.'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'simple proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.7', 'ciLowerLimit': '3.3', 'ciUpperLimit': '4.1', 'pValueComment': 'The threshold for statistical significance was p = 0.05', 'statisticalMethod': 'nonparametric bootstrap approach', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'The 95% CIs for differences were estimated using nonparametric bootstrap approach on the basis of 10,000 replicates with women as resampling units', 'nonInferiorityComment': 'We compared DBT false positive findings for first observer (usual care) vs DBT and WBUS false positive findings for first observer for Years/Screens 2 \\& 3.'}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': 'DBT false-positive findings for first observer (usual care) vs DBT and WBUS false positive findings for first observer', 'unitOfMeasure': 'percent of participants without cancer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Women who did not have a cancer diagnosis'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Whole Breast Ultrasound', 'description': 'All women will receive both 3D mammography and whole breast ultrasound for breast cancer screening; the order of interpretation will vary for each of two radiologists\n\nWhole breast ultrasound: Breast cancer screening with whole breast ultrasound'}], 'periods': [{'title': 'First Screening Round', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6266'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6178'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '88'}]}], 'dropWithdraws': [{'type': 'ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'excluded from analysis', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '56'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '28'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}, {'title': 'Between First and Second Screening', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6178'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6020'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '158'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '65'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '82'}]}, {'type': 'women who skipped year 2 exam', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}]}]}, {'title': 'Second Screening Round', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6020'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5937'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '83'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '57'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}, {'title': 'Between Second and Third Screening', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5937'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5680'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '257'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '75'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '181'}]}]}, {'title': 'Third Screening Round', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5680'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5437'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '243'}]}], 'dropWithdraws': [{'type': 'PI excluded', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '241'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6179', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Whole Breast Ultrasound', 'description': 'All women will receive both 3D mammography and whole breast ultrasound for breast cancer screening; the order of interpretation will vary for each of two radiologists\n\nWhole breast ultrasound: Breast cancer screening with whole breast ultrasound'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.8', 'spread': '8.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6179', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '6160', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '49', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '106', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '5991', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '6179', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Breast Density', 'classes': [{'categories': [{'title': 'scattered', 'measurements': [{'value': '203', 'groupId': 'BG000'}]}, {'title': 'heterogeneously dense', 'measurements': [{'value': '4989', 'groupId': 'BG000'}]}, {'title': 'extremely dense', 'measurements': [{'value': '987', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'After exclusions, we analyzed the results from 6,179 women overall'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-05-11', 'size': 257343, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-04-25T15:32', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6266}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2022-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-27', 'studyFirstSubmitDate': '2015-12-23', 'resultsFirstSubmitDate': '2023-04-26', 'studyFirstSubmitQcDate': '2015-12-30', 'lastUpdatePostDateStruct': {'date': '2023-06-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-06-27', 'studyFirstPostDateStruct': {'date': '2015-12-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cancer Yield Per 1,000', 'timeFrame': '3 Years', 'description': 'Results from the first radiologist observer are presented'}, {'measure': 'Sensitivity (True Positive Rate)', 'timeFrame': '3 years', 'description': 'DBT true positive findings for first observer (usual care) vs DBT and WBUS true positive findings for first observer'}, {'measure': 'False-positive Recall Rate', 'timeFrame': '3 years', 'description': 'DBT false-positive findings for first observer (usual care) vs DBT and WBUS false positive findings for first observer'}], 'secondaryOutcomes': [{'measure': 'Types of Abnormalities Detected by Ultrasound and Tomosynthesis', 'timeFrame': '3 years', 'description': 'Counts and percentages of participants diagnosed with cancer and detected by first observer with DBT only, DBT and WBUS, and WBUS only'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['whole breast ultrasound', 'digital breast tomosynthesis', 'breast density', 'breast cancer screening'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '36626696', 'type': 'DERIVED', 'citation': 'Berg WA, Zuley ML, Chang TS, Gizienski TA, Chough DM, Bohm-Velez M, Sharek DE, Straka MR, Hakim CM, Hartman JY, Harnist KS, Tyma CS, Kelly AE, Waheed U, Houshmand G, Nair BE, Shinde DD, Lu AH, Bandos AI, Berg JM, Lettiere NB, Ganott MA. Prospective Multicenter Diagnostic Performance of Technologist-Performed Screening Breast Ultrasound After Tomosynthesis in Women With Dense Breasts (the DBTUST). J Clin Oncol. 2023 May 1;41(13):2403-2415. doi: 10.1200/JCO.22.01445. Epub 2023 Jan 10.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the role of technologist-performed whole breast ultrasound for detecting breast cancer in the screening population of women with dense breasts.', 'detailedDescription': 'This is a prospective study designed to evaluate the role of whole breast ultrasound (WBUS) in screening for breast cancer. In particular, there is interest in investigating the value of using WBUS as an adjunct (supplementary imaging) to Digital Breast Tomosynthesis (DBT) based screening of women with dense (heterogeneously or extremely dense) breasts or as a primary screening examination in this group of women. Women scheduled for their routine mammography that includes a DBT exam who agree to participate in the study and sign informed consent will undergo (at the same visit) DBT imaging as part of their clinical exam and whole breast ultrasound (WBUS) each year for three rounds of screening plus one year of follow-up. The DBT images and WBUS will be interpreted independently by two experienced radiologists under standard clinical screening procedures. One radiologist will interpret the DBT and the other radiologist will interpret the WBUS. Using a modified "LOGICAL OR" approach women/subjects may be recalled for further diagnostic work-up (examinations). If a subject is recalled, she will then follow the standard/routine clinical procedures for follow-up and the investigators will verify outcomes. If neither radiologist recalls the subject, then the subject will follow conventional management and the investigators will verify outcome. The findings from the DBT and WBUS examinations, as well as any resulting follow-up, will be collected, recorded and analyzed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged 40 to 75 years of age with heterogeneously dense or extremely dense parenchyma by prior digital mammography report (i.e., "dense breasts"), presenting for routine annual mammography with digital breast tomosynthesis.\n\nExclusion Criteria:\n\n* Known to be at high risk for breast cancer due to known or suspected pathologic BRCA mutation (i.e. first-degree relative with known mutation) or prior chest radiation therapy before age 30;\n* No mammogram within the prior 3 years;\n* Signs or symptoms of breast disease including lump, bloody or spontaneous clear nipple discharge, eczema of the nipple;\n* Pregnancy or lactation within the prior 6 months;\n* Plan to become pregnant in the next two years, as mammography is not typically performed for screening pregnant women;\n* Breast implants, as assessment of breast density may be problematic;\n* Recent prior breast surgery or breast biopsy or cyst aspiration within the prior 12 months;\n* Prior or current malignancy other than the following: a) Breast cancer at least one year earlier (12 full months have elapsed since the last treatment surgery) with no known distant metastases and no known residual tumor; or b) Basal or squamous cell skin cancer or in situ cervical cancer or stage I thyroid cancer; or c) Other cancer for which the patient has been disease free for ≥ 5 years, with no recurrence of cancer in the last five years and no residual disease detected in the last five years.\n* Screening contrast-enhanced MRI or 99mTc-sestamibi based imaging of the breast(s) within the prior 12 months or planned within the next two years, to avoid contamination of results;\n* Unwilling or unable to provide consent.'}, 'identificationModule': {'nctId': 'NCT02643966', 'acronym': 'DBTUST', 'briefTitle': 'Assessment of Periodic Screening of Women With Denser Breast Using WBUS and DBT', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Assessment of Periodic Screening of Women With Denser Breast Using WBUS and DBT (Also Known as "DBTUST-Dense Breast Tomosynthesis / Ultrasound Screening Trial")', 'orgStudyIdInfo': {'id': 'PRO14100275'}, 'secondaryIdInfos': [{'id': 'R01CA187593-01A1', 'link': 'https://reporter.nih.gov/quickSearch/R01CA187593-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Whole breast ultrasound', 'description': 'All women will receive both 3D mammography and whole breast ultrasound for breast cancer screening; the order of interpretation will vary for each of two radiologists', 'interventionNames': ['Device: Whole breast ultrasound']}], 'interventions': [{'name': 'Whole breast ultrasound', 'type': 'DEVICE', 'description': 'Breast cancer screening with whole breast ultrasound', 'armGroupLabels': ['Whole breast ultrasound']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15206', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Weinstein Imaging Associates', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Magee-Womens Hospital', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Wendie Berg, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wendie Berg', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Radiology', 'investigatorFullName': 'Wendie Berg', 'investigatorAffiliation': 'University of Pittsburgh'}}}}