Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-02-20 @ 10:09 PM
Study NCT ID:
NCT02156258
Status:
COMPLETED
Last Update Posted:
2020-05-20
First Post:
2014-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Acquisition of Breast Mammography Images
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': 'randy.vader@fujifilm.com', 'phone': '360-356-6821', 'title': 'Randy Vader', 'organization': 'Fujifilm Medical Systems USA, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '20 months', 'description': 'Same definition applies for this study as indicated from clinicaltrials.gov.', 'eventGroups': [{'id': 'EG000', 'title': 'Diagnostic Cases', 'description': 'Collection of diagnostic cases (scheduled for biopsy due to BI-RADS 4 or 5) using Full Field Digital Mammography (FFDM) Mammography and Digital Breast Tomosynthesis (DBT) Mammography\n\nFFDM Mammography: Standard mammography image collection\n\nDBT Mammography: Collection of breast images using DBT mammography', 'otherNumAtRisk': 674, 'deathsNumAtRisk': 674, 'otherNumAffected': 1, 'seriousNumAtRisk': 674, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Recall Cases', 'description': 'Collection of Imaging Recall Cases using FFDM Mammography and DBT Mammography\n\nFFDM Mammography: Standard mammography image collection\n\nDBT Mammography: Collection of breast images using DBT mammography', 'otherNumAtRisk': 203, 'deathsNumAtRisk': 203, 'otherNumAffected': 0, 'seriousNumAtRisk': 203, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Screening Cases', 'description': 'Collection of Screening Cases (underwent routine screening mammography) using FFDM Mammography and DBT Mammography\n\nFFDM Mammography: Standard mammography image collection\n\nDBT Mammography: Collection of breast images using DBT mammography', 'otherNumAtRisk': 355, 'deathsNumAtRisk': 355, 'otherNumAffected': 0, 'seriousNumAtRisk': 355, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Syncope', 'notes': 'One subject fainted during the mammogram. The enrolling center determined that the event was not related to the study procedure and not related to the investigational device. The subject fully recovered before leaving the center.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 674, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants for Whom Study Image Data Were Collected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '674', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '355', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Diagnostic Cases', 'description': 'Collection of diagnostic cases (scheduled for biopsy due to BI-RADS 4 or 5) using Full Field Digital Mammography (FFDM) Mammography and Digital Breast Tomosynthesis (DBT) Mammography\n\nFFDM Mammography: Standard mammography image collection\n\nDBT Mammography: Collection of breast images using DBT mammography'}, {'id': 'OG001', 'title': 'Recall Cases', 'description': 'Collection of Imaging Recall Cases using FFDM Mammography and DBT Mammography\n\nFFDM Mammography: Standard mammography image collection\n\nDBT Mammography: Collection of breast images using DBT mammography'}, {'id': 'OG002', 'title': 'Screening Cases', 'description': 'Collection of Screening Cases (underwent routine screening mammography) using FFDM Mammography and DBT Mammography\n\nFFDM Mammography: Standard mammography image collection\n\nDBT Mammography: Collection of breast images using DBT mammography'}], 'classes': [{'categories': [{'measurements': [{'value': '642', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}, {'value': '244', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '20 Months', 'description': 'This study created a library of image data to be used in future projects, future product development and regulatory submissions. There was no analysis conducted aside from confirmation of complete images and collected data , as this was merely a collection of images to be used in future reader studies. Sites were provided a target distribution of diagnostic, recall and screening cases to obtain.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Difference between enrolled and analyzed are those that were discontinued due to not returning for 1 year follow-up, etc. All cases were reviewed to ensure complete images and data, that was the extent of the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Diagnostic Cases', 'description': 'Collection of diagnostic cases (scheduled for biopsy due to BI-RADS 4 or 5) using Full Field Digital Mammography (FFDM) Mammography and Digital Breast Tomosynthesis (DBT) Mammography\n\nFFDM Mammography: Standard mammography image collection\n\nDBT Mammography: Collection of breast images using DBT mammography'}, {'id': 'FG001', 'title': 'Recall Cases', 'description': 'Collection of Imaging Recall Cases using FFDM Mammography and DBT Mammography\n\nFFDM Mammography: Standard mammography image collection\n\nDBT Mammography: Collection of breast images using DBT mammography'}, {'id': 'FG002', 'title': 'Screening Cases', 'description': 'Collection of Screening Cases (underwent routine screening mammography) using FFDM Mammography and DBT Mammography\n\nFFDM Mammography: Standard mammography image collection\n\nDBT Mammography: Collection of breast images using DBT mammography'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '674'}, {'groupId': 'FG001', 'numSubjects': '203'}, {'groupId': 'FG002', 'numSubjects': '355'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '642'}, {'groupId': 'FG001', 'numSubjects': '124'}, {'groupId': 'FG002', 'numSubjects': '244'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '79'}, {'groupId': 'FG002', 'numSubjects': '111'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '674', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '355', 'groupId': 'BG002'}, {'value': '1232', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Diagnostic Cases', 'description': 'Collection of diagnostic cases (scheduled for biopsy due to BI-RADS 4 or 5) using Full Field Digital Mammography (FFDM) Mammography and Digital Breast Tomosynthesis (DBT) Mammography\n\nFFDM Mammography: Standard mammography image collection\n\nDBT Mammography: Collection of breast images using DBT mammography'}, {'id': 'BG001', 'title': 'Recall Cases', 'description': 'Collection of Imaging Recall Cases using FFDM Mammography and DBT Mammography\n\nFFDM Mammography: Standard mammography image collection\n\nDBT Mammography: Collection of breast images using DBT mammography'}, {'id': 'BG002', 'title': 'Screening Cases', 'description': 'Collection of Screening Cases (underwent routine screening mammography) using FFDM Mammography and DBT Mammography\n\nFFDM Mammography: Standard mammography image collection\n\nDBT Mammography: Collection of breast images using DBT mammography'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '518', 'groupId': 'BG000'}, {'value': '164', 'groupId': 'BG001'}, {'value': '274', 'groupId': 'BG002'}, {'value': '956', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '156', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}, {'value': '276', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '674', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '355', 'groupId': 'BG002'}, {'value': '1232', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '158', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '564', 'groupId': 'BG000'}, {'value': '161', 'groupId': 'BG001'}, {'value': '316', 'groupId': 'BG002'}, {'value': '1041', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '674', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '355', 'groupId': 'BG002'}, {'value': '1232', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1232}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-08', 'studyFirstSubmitDate': '2014-06-02', 'resultsFirstSubmitDate': '2020-03-27', 'studyFirstSubmitQcDate': '2014-06-03', 'lastUpdatePostDateStruct': {'date': '2020-05-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-05-08', 'studyFirstPostDateStruct': {'date': '2014-06-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants for Whom Study Image Data Were Collected', 'timeFrame': '20 Months', 'description': 'This study created a library of image data to be used in future projects, future product development and regulatory submissions. There was no analysis conducted aside from confirmation of complete images and collected data , as this was merely a collection of images to be used in future reader studies. Sites were provided a target distribution of diagnostic, recall and screening cases to obtain.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Imaging', 'Mammography'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This is a case collection study of breast images using standard and new mammography technology.', 'detailedDescription': 'This image acquisition study is designed to acquire the study image data and establish and document the clinical findings for each subject. This study will create a library of image data that will be used for future projects.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A total of at least 200 cancer, 175 recall cases and 350 negative/benign cases will be accumulated', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nFor Screening Subjects\n\n* Be at least 40 years of age, are\n* Asymptomatic,\n* Scheduled for a routine screening mammogram\n\nFor Recall Subjects\n\n* Be at least 18 years of age,\n* Received a BIRADS 0 within the last 60 days\n* Are recalled for additional imaging\n\nFor Diagnostic Subjects\n\n* Be at least 18 years of age,\n* Scheduled for a biopsy due to an assessment of Breast Imaging and Reporting Data (BI-RADS®) 4 or 5 after diagnostic work-up of a suspicious screening or clinical finding within the last 60 days.\n* Understand requirements and willing to participate in study\n\nExclusion Criteria:\n\n* Presence of a breast implant.\n* Women with only a single breast; for example, post mastectomy patients.\n* Is pregnant or believes she may be pregnant.\n* A woman who has delivered and who has expressed the intention to breast-feed or is currently breast-feeding.\n* A woman who has significant existing breast trauma within the last one year.\n* Have self-reported severe non-focal or bilateral breast pain affecting subject's ability to tolerate digital mammography and/or breast tomosynthesis examinations.\n* A woman who has had a mammogram performed for the purpose of therapy portal planning within the last year.\n* Cannot, for any known reason, undergo follow-up digital mammography and/or breast tomosynthesis examinations (where clinically indicated) at the participating institution.\n* Is an inmate (see US Code of Federal Regulations 45CFR46.306)."}, 'identificationModule': {'nctId': 'NCT02156258', 'briefTitle': 'Acquisition of Breast Mammography Images', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fujifilm Medical Systems USA, Inc.'}, 'officialTitle': 'Acquisition of Digital Mammography and Breast Images for Clinical Evaluation of FujifilmDigital Breast Tomosynthesis', 'orgStudyIdInfo': {'id': 'FMSU2013-004A'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diagnostic Cases', 'description': 'Collection of cases that were scheduled for biopsy (BI-RADS 4 or 5) using Full Field Digital Mammography (FFDM) Mammography and Digital Breast Tomosynthesis (DBT) Mammography', 'interventionNames': ['Device: FFDM Mammography', 'Device: DBT Mammography']}, {'label': 'Recall Cases', 'description': 'Collection of Imaging Recall Cases (were scheduled for additional imaging due an assessment of BI-RADS 0) using FFDM Mammography and DBT Mammography', 'interventionNames': ['Device: FFDM Mammography', 'Device: DBT Mammography']}, {'label': 'Screening Cases', 'description': 'Collection of cases who underwent routine screening mammography using FFDM Mammography and DBT Mammography', 'interventionNames': ['Device: FFDM Mammography', 'Device: DBT Mammography']}], 'interventions': [{'name': 'FFDM Mammography', 'type': 'DEVICE', 'description': 'Standard mammography image collection', 'armGroupLabels': ['Diagnostic Cases', 'Recall Cases', 'Screening Cases']}, {'name': 'DBT Mammography', 'type': 'DEVICE', 'description': 'Collection of breast images using DBT mammography', 'armGroupLabels': ['Diagnostic Cases', 'Recall Cases', 'Screening Cases']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Scottsdale Medical Imaging, Ltd', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Hospitals & Clinics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '14620', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Elizabeth Wende Breast Care, LLC', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina - at Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center at San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Etta D Pissano, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of South Carolina'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fujifilm Medical Systems USA, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}