Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-02-21 @ 9:24 PM
Study NCT ID:
NCT02042456
Status:
TERMINATED
Last Update Posted:
2015-10-20
First Post:
2014-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Automated Breast Ultrasound and Digital Breast Tomosynthesis Screening Compared to Full Field Digital Mammography in Women With Dense Breasts
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008327', 'term': 'Mammography'}], 'ancestors': [{'id': 'D011859', 'term': 'Radiography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Change in study staff at the site, change in Sponsor direction', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-16', 'studyFirstSubmitDate': '2014-01-20', 'studyFirstSubmitQcDate': '2014-01-21', 'lastUpdatePostDateStruct': {'date': '2015-10-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Abnormal interpretation rate', 'timeFrame': 'One Year', 'description': 'Abnormal interpretation rates for each modality (FFDM and DBT+V-Preview, with and without ABUS+V-Preview).'}], 'secondaryOutcomes': [{'measure': 'Sensitivity', 'timeFrame': 'One Year', 'description': 'Sensitivity will be assessed for each imaging modality: FFDM and DBT+V-Preview, with and without ABUS'}, {'measure': 'Specificity', 'timeFrame': 'One Year', 'description': 'Specificity will be assessed for each imaging modality: FFDM and DBT+V-Preview, with and without ABUS'}, {'measure': 'Cancer Rate', 'timeFrame': 'One Year', 'description': 'Cancer Rate will be assessed for each imaging modality: FFDM and DBT+V-Preview, with and without ABUS'}, {'measure': 'Positive Predictive Value', 'timeFrame': 'One Year', 'description': 'Positive Predictive Value will be assessed for each imaging modality: FFDM and DBT+V-Preview, with and without ABUS'}, {'measure': 'Negative Predictive Value', 'timeFrame': 'One Year', 'description': 'Negative Predictive Value will be assessed for each imaging modality: FFDM and DBT+V-Preview, with and without ABUS'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['breast cancer', 'dense breasts', 'mammography screening', 'Screening techniques', 'women'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This study is investigating whether automated whole breast ultrasound can improve detection of cancer in breast cancer screening when used as a supplement to mammography or as a supplement to digital breast tomosynthesis'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects will be selected from the patients arriving at the clinic for yearly breast cancer screening exams', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Able and willing to provide signed declaration of informed consent or have a legally authorized representative provide signed declaration of informed consent for participation in all study procedures;\n* Women aged ≥18 years at the time of enrollment;\\*\n* Women with a previous determination of dense breasts determined by mammogram as heterogeneously dense or extremely dense;\n* At moderately increased or high risk (\\>15% lifetime risk) for breast cancer based on meeting one or more of the ACS criteria 1:\n\nAND Referred for screening mammography\n\nExclusion Criteria:\n\n* Have been screened using any breast imaging technology in \\<12 months immediately prior to enrollment;\n* Exhibit breast cancer symptoms according to assessment by the subject's health care provider within one year prior to enrollment;\n* Diagnosed with breast cancer, with or without metastasis, within one year prior to enrollment;\n* Are currently pregnant as determined per standard clinical practice at the investigational site;\n* Present with contraindications to any imaging examination required in the study protocol;\n* Have breast implants; OR\n* Are lactating."}, 'identificationModule': {'nctId': 'NCT02042456', 'briefTitle': 'Automated Breast Ultrasound and Digital Breast Tomosynthesis Screening Compared to Full Field Digital Mammography in Women With Dense Breasts', 'organization': {'class': 'INDUSTRY', 'fullName': 'GE Healthcare'}, 'officialTitle': 'Automated Breast Ultrasound and Digital Breast Tomosynthesis Screening Compared to Full Field Digital Mammography in Women With Dense Breasts', 'orgStudyIdInfo': {'id': '124.03-2013-GES-0003'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Main Cohort', 'description': 'Subjects enrolled in this group will receive a full field digital mammogram, digital breast tomosynthesis exam and an automated whole breast ultrasound exam as part of their visit.', 'interventionNames': ['Device: Digital Breast Tomosynthesis', 'Device: Automated Whole Breast Ultrasound', 'Device: Full Field Digital Mammography']}], 'interventions': [{'name': 'Digital Breast Tomosynthesis', 'type': 'DEVICE', 'otherNames': ['GE SenoClaire DBT with V-Preview'], 'description': 'digital breast tomosynthesis technology', 'armGroupLabels': ['Main Cohort']}, {'name': 'Automated Whole Breast Ultrasound', 'type': 'DEVICE', 'otherNames': ['Invenia ABUS'], 'description': 'Automated Whole Breast Ultrasound', 'armGroupLabels': ['Main Cohort']}, {'name': 'Full Field Digital Mammography', 'type': 'DEVICE', 'armGroupLabels': ['Main Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington Seattle Cancer Care Alliance', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GE Healthcare', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}