Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-02-25 @ 4:40 PM
Study NCT ID:
NCT02324205
Status:
TERMINATED
Last Update Posted:
2019-02-26
First Post:
2014-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to Mammography (ADAPT)
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'}]}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Sara.J.Lam@ge.com', 'phone': '1-262-548-2369', 'title': 'Sara Lam', 'organization': 'GE Healthcare'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse Event data were collected from June 2015 to November 2016 (1 year and 5 months).', 'eventGroups': [{'id': 'EG000', 'title': 'DBT and FFDM', 'description': 'Subjects underwent 2D breast imaging with full-field digital mammography (FFDM) followed by 3D breast imaging with digital breast tomosynthesis (DBT). Digital Breast Tomosynthesis: 3D imaging of the breast using Digital Breast Tomosynthesis (DBT) device. Full-Field Digital Mammography: 2D imaging of the breast using Full-Field Digital Mammography (FFDM) device.\n\nDBT and FFDM: Subjects underwent breast imaging using each device: DBT and FFDM.', 'otherNumAtRisk': 196, 'deathsNumAtRisk': 196, 'otherNumAffected': 0, 'seriousNumAtRisk': 196, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With DBT, FFDM and Biopsy Specimens Collected.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DBT and FFDM', 'description': 'Participants underwent 2D breast imaging with full-field digital mammography (FFDM) and by 3D breast imaging with digital breast tomosynthesis (DBT). Digital Breast Tomosynthesis: 3D imaging of the breast using Digital Breast Tomosynthesis (DBT) device. Full-Field Digital Mammography: 2D imaging of the breast using Full-Field Digital Mammography (FFDM) device.\n\nSubjects also were referred (per standard of care) for a biopsy. Specimen was collected, and result was recorded.'}], 'classes': [{'categories': [{'title': 'Participants that completed DBT, FFDM and Biopsy', 'measurements': [{'value': '159', 'groupId': 'OG000'}]}, {'title': 'Participants that did not complete all three tests', 'measurements': [{'value': '37', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Approximately 8 weeks', 'description': 'For each participant, obtain image data using two methods (DBT and FFDM) and obtain histology results of biopsy specimens from women referred for biopsy.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Initially asymptomatic adult women presenting for breast biopsy based on prior breast imaging.'}, {'type': 'SECONDARY', 'title': 'Lesion Type Observed by FFDM Imaging', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}, {'units': 'lesions', 'counts': [{'value': '173', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DBT and FFDM', 'description': 'Participants underwent 2D breast imaging with full-field digital mammography (FFDM) and by 3D breast imaging with digital breast tomosynthesis (DBT). Digital Breast Tomosynthesis: 3D imaging of the breast using Digital Breast Tomosynthesis (DBT) device. Full-Field Digital Mammography: 2D imaging of the breast using Full-Field Digital Mammography (FFDM) device.\n\nSubjects also were referred (per standard of care) for a biopsy. Specimen was collected, and result was recorded.'}], 'classes': [{'title': 'Lesion description = mass', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}]}]}, {'title': 'Lesion description = calcification', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}]}]}, {'title': 'Lesion description = all other', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Approximately 8 weeks', 'description': 'Lesions were characterized based on findings identified during image evaluations performed by qualified readers.', 'unitOfMeasure': 'lesions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'lesions', 'denomUnitsSelected': 'lesions', 'populationDescription': 'Participants with lesions evaluated by FFDM. A single participant may have more than one lesion.'}, {'type': 'SECONDARY', 'title': 'Lesion Type Observed by DBT Imaging', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}, {'units': 'lesions', 'counts': [{'value': '192', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DBT and FFDM', 'description': 'Participants underwent 2D breast imaging with full-field digital mammography (FFDM) and by 3D breast imaging with digital breast tomosynthesis (DBT). Digital Breast Tomosynthesis: 3D imaging of the breast using Digital Breast Tomosynthesis (DBT) device. Full-Field Digital Mammography: 2D imaging of the breast using Full-Field Digital Mammography (FFDM) device.\n\nSubjects also were referred (per standard of care) for a biopsy. Specimen was collected, and result was recorded.'}], 'classes': [{'title': 'Lesion description = mass', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}]}]}, {'title': 'Lesion description = calcification', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}]}]}, {'title': 'Lesion description = all other', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Approximately 8 weeks', 'description': 'Lesions were characterized based on findings identified during image evaluations performed by qualified researchers.', 'unitOfMeasure': 'lesions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'lesions', 'denomUnitsSelected': 'lesions', 'populationDescription': 'Participants with DBT breast images collected, and lesion characteristic described by qualified reader. Participants may have more than one lesion.'}, {'type': 'SECONDARY', 'title': 'Maximum Lesion Dimension as Observed by FFDM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}, {'units': 'lesions', 'counts': [{'value': '166', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DBT and FFDM', 'description': 'Participants underwent 2D breast imaging with full-field digital mammography (FFDM) and by 3D breast imaging with digital breast tomosynthesis (DBT). Digital Breast Tomosynthesis: 3D imaging of the breast using Digital Breast Tomosynthesis (DBT) device. Full-Field Digital Mammography: 2D imaging of the breast using Full-Field Digital Mammography (FFDM) device.\n\nSubjects also were referred (per standard of care) for a biopsy. Specimen was collected, and result was recorded.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.45', 'spread': '9.89', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Approximately 8 weeks', 'description': 'Maximum Length of Lesions (measured in mm) when images were collected using FFDM.', 'unitOfMeasure': 'millimeters (mm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'lesions', 'denomUnitsSelected': 'lesions', 'populationDescription': 'Lesions observed and measured when images were collected when using FFDM; Seven (7) of the total 173 observed lesions were not measured.'}, {'type': 'SECONDARY', 'title': 'Maximum Lesion Dimension as Observed by DBT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}, {'units': 'Lesions', 'counts': [{'value': '176', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DBT and FFDM', 'description': 'Participants underwent 2D breast imaging with full-field digital mammography (FFDM) and by 3D breast imaging with digital breast tomosynthesis (DBT). Digital Breast Tomosynthesis: 3D imaging of the breast using Digital Breast Tomosynthesis (DBT) device. Full-Field Digital Mammography: 2D imaging of the breast using Full-Field Digital Mammography (FFDM) device.\n\nSubjects also were referred (per standard of care) for a biopsy. Specimen was collected, and result was recorded.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.24', 'spread': '9.09', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Approximately 8 weeks', 'description': 'Maximum length of lesions (measured in mm) when images were collected using DBT', 'unitOfMeasure': 'millimeters (mm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lesions', 'denomUnitsSelected': 'Lesions', 'populationDescription': 'Lesions observed and measured when images were collected using DBT. Sixteen (16) of the total 192 observed lesions were not measured.'}, {'type': 'SECONDARY', 'title': 'Biopsy Finding of Lesions Per Subject.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DBT and FFDM', 'description': 'Participants underwent 2D breast imaging with full-field digital mammography (FFDM) and by 3D breast imaging with digital breast tomosynthesis (DBT). Digital Breast Tomosynthesis: 3D imaging of the breast using Digital Breast Tomosynthesis (DBT) device. Full-Field Digital Mammography: 2D imaging of the breast using Full-Field Digital Mammography (FFDM) device.\n\nSubjects also were referred (per standard of care) for a biopsy. Specimen was collected, and result was recorded.'}], 'classes': [{'title': 'Lesions identified as "positive/malignant"', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}]}]}, {'title': 'Lesions identified as "negative/benign"', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}]}]}, {'title': 'Biopsy was no-conclusive', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Approximately 8 weeks', 'description': 'Describes histologic cancer and non-cancer findings of lesion biopsy. Cancer status of lesions was reported per subject, not per lesion.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All lesions with a biopsy finding: "positive/malignant", "negative/benign" or "non-conclusive". Biopsy findings were reported per subject, not per lesion.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Safety - Device Related Malfunctions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DBT and FFDM', 'description': 'Participants underwent 2D breast imaging with full-field digital mammography (FFDM) and by 3D breast imaging with digital breast tomosynthesis (DBT). Digital Breast Tomosynthesis: 3D imaging of the breast using Digital Breast Tomosynthesis (DBT) device. Full-Field Digital Mammography: 2D imaging of the breast using Full-Field Digital Mammography (FFDM) device.\n\nSubjects also were referred (per standard of care) for a biopsy. Specimen was collected, and result was recorded.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'less than 16 months', 'description': 'Number of device-related malfunctions by imaging modality.', 'unitOfMeasure': 'malfunction events reported', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of device malfunctions recorded for either DBT or FFDM imaging.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DBT and FFDM', 'description': 'Subjects underwent 2D breast imaging with full-field digital mammography (FFDM) followed by 3D breast imaging with digital breast tomosynthesis (DBT). Digital Breast Tomosynthesis: 3D imaging of the breast using Digital Breast Tomosynthesis (DBT) device. Full-Field Digital Mammography: 2D imaging of the breast using Full-Field Digital Mammography (FFDM) device.\n\nDBT and FFDM: Subjects underwent breast imaging using each device: DBT and FFDM.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '196'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '159'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '37'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'DBT and FFDM', 'description': 'Subjects underwent 2D breast imaging with full-field digital mammography (FFDM) followed by 3D breast imaging with digital breast tomosynthesis (DBT). Digital Breast Tomosynthesis: 3D imaging of the breast using Digital Breast Tomosynthesis (DBT) device. Full-Field Digital Mammography: 2D imaging of the breast using Full-Field Digital Mammography (FFDM) device.\n\nDBT and FFDM: Subjects underwent breast imaging using each device: DBT and FFDM.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age 30 years and greater', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '196', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '196', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], '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': '196', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '136', 'groupId': 'BG000'}]}]}, {'title': 'France', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-03-08', 'size': 546254, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-10-29T10:33', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All participants underwent 2D breast imaging with Full-field digital mammography (FFDM) and by 3D breast imaging with Digital Breast Tomosynthesis (DBT).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 196}}, 'statusModule': {'whyStopped': 'Sponsor met enroll. need for planned second study before meeting enroll. ceiling in protocol', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2017-08-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-05', 'studyFirstSubmitDate': '2014-12-11', 'resultsFirstSubmitDate': '2018-12-19', 'studyFirstSubmitQcDate': '2014-12-23', 'lastUpdatePostDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-02-05', 'studyFirstPostDateStruct': {'date': '2014-12-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Safety - Device Related Malfunctions', 'timeFrame': 'less than 16 months', 'description': 'Number of device-related malfunctions by imaging modality.'}], 'primaryOutcomes': [{'measure': 'Number of Participants With DBT, FFDM and Biopsy Specimens Collected.', 'timeFrame': 'Approximately 8 weeks', 'description': 'For each participant, obtain image data using two methods (DBT and FFDM) and obtain histology results of biopsy specimens from women referred for biopsy.'}], 'secondaryOutcomes': [{'measure': 'Lesion Type Observed by FFDM Imaging', 'timeFrame': 'Approximately 8 weeks', 'description': 'Lesions were characterized based on findings identified during image evaluations performed by qualified readers.'}, {'measure': 'Lesion Type Observed by DBT Imaging', 'timeFrame': 'Approximately 8 weeks', 'description': 'Lesions were characterized based on findings identified during image evaluations performed by qualified researchers.'}, {'measure': 'Maximum Lesion Dimension as Observed by FFDM', 'timeFrame': 'Approximately 8 weeks', 'description': 'Maximum Length of Lesions (measured in mm) when images were collected using FFDM.'}, {'measure': 'Maximum Lesion Dimension as Observed by DBT', 'timeFrame': 'Approximately 8 weeks', 'description': 'Maximum length of lesions (measured in mm) when images were collected using DBT'}, {'measure': 'Biopsy Finding of Lesions Per Subject.', 'timeFrame': 'Approximately 8 weeks', 'description': 'Describes histologic cancer and non-cancer findings of lesion biopsy. Cancer status of lesions was reported per subject, not per lesion.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Breast Cancer', 'Tumors, Breast']}, 'descriptionModule': {'briefSummary': 'The aim of this recruitment plan (ADAPT-BX) is to collect image and technical data on both digital breast tomosynthesis (DBT) and full-field digital mammography (FFDM), along with other subject data including histology results from biopsy specimen examination and cancer classification data from initially asymptomatic women referred for biopsy after recall from screening and diagnostic work-up. These data will be included in a subsequent and prospectively planned pooled analysis described in a separate protocol (ADAPT-BIE) examining superiority of DBT to FFDM for breast cancer diagnosis and other clinical performance measures.', 'detailedDescription': 'ADAPT program consists of 2 recruitment plans (ADAPT-SCR and ADAPT-BX) followed by an off-line read of the images and data collected (ADAPT-BIE). This study involves the comparison of two devices that can identify abnormalities in routine breast screening and diagnostic mammography. Mammography is usually done with full-field digital mammography (FFDM), which takes flat, two-dimensional X-ray images of the breast. Doctors use the two-dimensional images to look for cancers and other abnormal tissue. The purpose of this study is to learn more about the accuracy of full-field digital mammography devices and a new mammography device called digital breast tomosynthesis (DBT). DBT is similar to full-field digital mammography, but can also move around the breast to get X-ray images from different angles, which provides a three-dimensional view that doctors can use to look for cancers and abnormal tissue. Subjects will be recruited from an initially asymptomatic population that have been referred for clinically indicated breast biopsy based on suspicious breast imaging results. Subjects will undergo a DBT mammogram prior to biopsy. If FFDM was not performed within 30 days, subjects will also undergo FFDM prior to biopsy. Results of biopsy(ies) and histopathology, including lesion characteristics, will be recorded and considered as truth if positive for cancer status. Subjects with negative or benign histological findings will be followed for approximately one year (10-16 months) by FFDM and any additional standard of care practice.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Women aged 30 years or older (≥30 years old);\n* Initially asymptomatic women that underwent routine screening FFDM, breast ultrasound (U/S), breast magnetic resonance imaging (MRI) and/or DBT, followed by diagnostic work-up showing one of more abnormalities and referred for breast biopsy within of 30 days before study entry;\n* Are able and willing to comply with study procedures;\n* Have signed and dated the informed consent form;\n* Documented as non-pregnant based on the investigator's medical judgment and in consideration of local clinical practice standards for evidence of non-pregnancy.\n\nExclusion Criteria:\n\n* Have been previously included in this study;\n* Have undergone diagnostic or surgical intervention(s) or procedure(s) on either breast, including mastectomy and cytopunction, before study-related imaging;\n* Have breasts too large to be adequately positioned on 24 x 31 centimeter (cm) FFDM digital receptor without anatomical cut off during a DBT examination (or FFDM, if required);\n* Have participated in (within the prior 30 days), another trial of an investigational product expected to interfere with study procedures or outcomes;\n* Have breast implant(s);\n* Have reconstructed breast(s)."}, 'identificationModule': {'nctId': 'NCT02324205', 'acronym': 'ADAPT', 'briefTitle': 'Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to Mammography (ADAPT)', 'organization': {'class': 'INDUSTRY', 'fullName': 'GE Healthcare'}, 'officialTitle': 'Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to Mammography (ADAPT Trial) ADAPT-BX: Recruitment Plan for Initially Asymptomatic Women Referred for Breast Biopsy', 'orgStudyIdInfo': {'id': '124.03-2014-GES-0010_2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DBT and FFDM', 'description': 'Subjects underwent 2D breast imaging with full-field digital mammography (FFDM) followed by 3D breast imaging with digital breast tomosynthesis (DBT). Digital Breast Tomosynthesis: 3D imaging of the breast using Digital Breast Tomosynthesis (DBT) device. Full-Field Digital Mammography: 2D imaging of the breast using Full-Field Digital Mammography (FFDM) device.', 'interventionNames': ['Device: DBT and FFDM']}], 'interventions': [{'name': 'DBT and FFDM', 'type': 'DEVICE', 'otherNames': ['Digital Breast Tomosynthesis (3D breast imaging) and Full-Field Digital Mammography (2D breast imaging)', '3D breast imaging and 2D breast imaging'], 'description': 'Subjects underwent breast imaging using each device: DBT and FFDM.', 'armGroupLabels': ['DBT and FFDM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33486', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': "Boca Raton Regional Hospital Christine E. Lynn Women's Health and Wellness Institute", 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '08043', 'city': 'Voorhees Township', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Cooper Health - Cooper Breast Imaging Centers', 'geoPoint': {'lat': 40.4795, 'lon': -74.49062}}, {'zip': '94805', 'city': 'Villejuif', 'country': 'France', 'facility': 'Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'overallOfficials': [{'name': 'Corinne Balleyguier, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gustave Roussy, Cancer Campus, Grand Paris'}, {'name': 'Lydia Liao, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cooper Health'}, {'name': 'Kathy Schilling, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boca Raton Regional Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GE Healthcare', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}