Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2026-02-22 @ 4:52 PM
Study NCT ID:
NCT03501693
Status:
COMPLETED
Last Update Posted:
2023-09-21
First Post:
2018-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Fujifilm DBT Plus S-View Versus FFDM Alone in the Detection of Breast Cancer - A Pivotal Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}}}}, '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': 'randy.vader@fujifilm.com', 'phone': '360-356-6821', 'title': 'Randy Vader', 'organization': 'Fujifilm Medical Systems USA, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'approximately 5 weeks', 'description': "There were no AE's expected for this study, as it was a radiologist reader study utilizing retrospective imaging. No study subjects were on-site for this retrospective review. No Adverse Events to report.", 'eventGroups': [{'id': 'EG000', 'title': 'DBT Plus S-View', 'description': 'Breast images utilizing DBT plus S-View\n\nDBT plus S-View: DBT plus S-View images', 'otherNumAtRisk': 300, 'deathsNumAtRisk': 300, 'otherNumAffected': 0, 'seriousNumAtRisk': 300, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'FFDM Alone', 'description': 'FFDM alone images\n\nFFDM Alone: FFDM alone images', 'otherNumAtRisk': 300, 'deathsNumAtRisk': 300, 'otherNumAffected': 0, 'seriousNumAtRisk': 300, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Compare Per Subject AUC: DBT Plus S-View Versus FFDM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DBT Plus S-View', 'description': 'Breast images utilizing DBT plus S-View\n\nDBT plus S-View: DBT plus S-View images'}, {'id': 'OG001', 'title': 'FFDM Alone', 'description': 'FFDM alone images\n\nFFDM Alone: FFDM alone images'}], 'classes': [{'categories': [{'measurements': [{'value': '0.794', 'spread': '0.032', 'groupId': 'OG000'}, {'value': '0.764', 'spread': '0.035', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Average of each radiologist reader\'s ROC (receiving operating characteristic curve) based on per-subject POM (probability of malignancy) scores requiring correct lesion localization. A ROC curve is a plot of Sensitivity versus 1-Specificity and is a summary of diagnostic performance of a device or clinician. The reader will first record whether there are mammographic findings and an initial BI-RADS assessment of 0, 1, or 2. If the answer to this question is "no" the reader will be asked to confirm for this case: a BI-RADS assessment category of 1 or 2, a Probability of Malignancy (POM) score following the POM guidance provided in the protocol, and recall decision of "no". If the reader answers "yes" to whether there are mammographic findings, the reader will be asked to confirm an initial BI-RADS assessment category of 0, and will then provide detailed information on each suspicious finding (up to three findings) and the decision whether or not to recall the subject.', 'unitOfMeasure': 'Probability', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Retrospective images used from Fujifilm protocol FMSU2013-004A. All readers read the same 300 images in their own randomized order during 2 sessions (they read half of each modality at each session which were separated by a 4 week washout period).'}, {'type': 'SECONDARY', 'title': 'Compare Per-subject Average Recall Rate for All Non-cancer Cases for DBT Plus S-View Versus FFDM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DBT Plus S-View', 'description': 'Breast images utilizing DBT plus S-View\n\nDBT plus S-View: DBT plus S-View images'}, {'id': 'OG001', 'title': 'FFDM Alone', 'description': 'FFDM alone images\n\nFFDM Alone: FFDM alone images'}], 'classes': [{'categories': [{'measurements': [{'value': '0.342', 'spread': '0.026', 'groupId': 'OG000'}, {'value': '0.415', 'spread': '0.027', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Based on recall rate for all non-cancer cases for DBT plus S-View versus FFDM, using non-inferiority margin delta = 0.05. The reader will first record whether there are mammographic findings and an initial BI-RADS assessment of 0, 1, or 2. If the answer to this question is "no" the reader will be asked to confirm for this case: a BI-RADS assessment category of 1 or 2, a Probability of Malignancy (POM) score following the POM guidance provided in the protocol, and recall decision of "no". If the reader answers "yes" to whether there are mammographic findings, the reader will be asked to confirm an initial BI-RADS assessment category of 0, and will then provide detailed information on each suspicious finding (up to three findings) and the decision whether or not to recall the subject, as well as overall POM score and BI-RADS assessment category.', 'unitOfMeasure': 'Proportion of cases correctly recalled', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '240 non-cancer cases evaluated out of 300 total cases acquired under Fujifilm protocol FMSU2013-004A.'}, {'type': 'SECONDARY', 'title': 'Compare Per-subject Average Recall Rate for DBT Plus S-View Versus FFDM for All Cancer Cases', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DBT Plus S-View', 'description': 'Breast images utilizing DBT plus S-View\n\nDBT plus S-View: DBT plus S-View images'}, {'id': 'OG001', 'title': 'FFDM Alone', 'description': 'FFDM alone images\n\nFFDM Alone: FFDM alone images'}], 'classes': [{'categories': [{'measurements': [{'value': '0.679', 'spread': '0.048', 'groupId': 'OG000'}, {'value': '0.643', 'spread': '0.049', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Based on recall rate for all cancer cases for DBT plus S-View versus FFDM, using non-inferiority margin delta = 0.10. The reader will first record whether there are mammographic findings and an initial BI-RADS assessment of 0, 1, or 2. If the answer to this question is "no" the reader will be asked to confirm for this case: a BI-RADS assessment category of 1 or 2, a Probability of Malignancy (POM) score following the POM guidance provided in the protocol, and recall decision of "no". If the reader answers "yes" to whether there are mammographic findings, the reader will be asked to confirm an initial BI-RADS assessment category of 0, and will then provide detailed information on each suspicious finding (up to three findings) and the decision whether or not to recall the subject, as well as overall POM score and BI-RADS assessment category.', 'unitOfMeasure': 'Proportion of cases correctly recalled', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '60 cancer cases were read (out of the total of 300 cases) from the previously acquired Fujifilm FMSU2013-004A acquisition study.'}, {'type': 'SECONDARY', 'title': 'Compare Per-subject Average Sensitivity for DBT Plus S-View Versus FFDM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DBT Plus S-View', 'description': 'Breast images utilizing DBT plus S-View\n\nDBT plus S-View: DBT plus S-View images'}, {'id': 'OG001', 'title': 'FFDM Alone', 'description': 'FFDM alone images\n\nFFDM Alone: FFDM alone images'}], 'classes': [{'categories': [{'measurements': [{'value': '0.679', 'spread': '0.048', 'groupId': 'OG000'}, {'value': '0.643', 'spread': '0.049', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Four weeks', 'description': 'Based on forced BI-RADS scores requiring correct lesion localization, using non-inferiority margin delta = 0.10. The reader will first record whether there are mammographic findings and an initial BI-RADS assessment of 0, 1, or 2. If the answer to this question is "no" the reader will be asked to confirm for this case: a BI-RADS assessment category of 1 or 2, a Probability of Malignancy (POM) score following the POM guidance provided in the protocol, and recall decision of "no". If the reader answers "yes" to whether there are mammographic findings, the reader will be asked to confirm an initial BI-RADS assessment category of 0, and will then provide detailed information on each suspicious finding (up to three findings) and the decision whether or not to recall the subject, as well as overall POM score and BI-RADS assessment category.', 'unitOfMeasure': 'Probability', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Sensitivity was analyzed in 60 cancer cases.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DBT Plus S-View, Then FFDM Only', 'description': 'Readers will read half of the DBT plus S-View images followed by half of the FFDM only images at each of 2 sessions. There was a four week memory washout period between the 2 sessions.'}, {'id': 'FG001', 'title': 'FFDM Only, Then DBT Plus S-View', 'description': 'Readers will read half of the FFDM images followed by half of the DBT plus S-Viewonly images at each of 2 sessions. There was a four week memory washout period between the 2 sessions.'}], 'periods': [{'title': 'First Reading Session', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '75'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '75'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': '4 Week Memory Washout Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '75'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '75'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Reading Session', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '75'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '75'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'This was a retrospective, multi-reader multi-case reader study. 18 radiologist readers read all 300 cases (half FFDM and half DBT plus S-View reads) at each of 2 visits which were separated by a memory washout period of approximately 4 weeks. Images were previously acquired under Fujifilm protocol FMSU2013-004A.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'DBT Plus S-View and FFDM Alone', 'description': '300 retrospectively collected breast images to be reviewed (both DBT plus S-View and FFDM alone for all 300 images)'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Particant Age Mean', 'categories': [{'measurements': [{'value': '56.5', 'spread': '10.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '300', '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': '28', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '260', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '12', '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': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '270', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '300', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-03-14', 'size': 1178228, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-04-17T09:46', 'hasProtocol': True}, {'date': '2018-04-05', 'size': 3742353, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-04-17T09:48', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-15', 'studyFirstSubmitDate': '2018-04-02', 'resultsFirstSubmitDate': '2020-04-17', 'studyFirstSubmitQcDate': '2018-04-10', 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-05-19', 'studyFirstPostDateStruct': {'date': '2018-04-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare Per Subject AUC: DBT Plus S-View Versus FFDM', 'timeFrame': '4 weeks', 'description': 'Average of each radiologist reader\'s ROC (receiving operating characteristic curve) based on per-subject POM (probability of malignancy) scores requiring correct lesion localization. A ROC curve is a plot of Sensitivity versus 1-Specificity and is a summary of diagnostic performance of a device or clinician. The reader will first record whether there are mammographic findings and an initial BI-RADS assessment of 0, 1, or 2. If the answer to this question is "no" the reader will be asked to confirm for this case: a BI-RADS assessment category of 1 or 2, a Probability of Malignancy (POM) score following the POM guidance provided in the protocol, and recall decision of "no". If the reader answers "yes" to whether there are mammographic findings, the reader will be asked to confirm an initial BI-RADS assessment category of 0, and will then provide detailed information on each suspicious finding (up to three findings) and the decision whether or not to recall the subject.'}], 'secondaryOutcomes': [{'measure': 'Compare Per-subject Average Recall Rate for All Non-cancer Cases for DBT Plus S-View Versus FFDM', 'timeFrame': '4 weeks', 'description': 'Based on recall rate for all non-cancer cases for DBT plus S-View versus FFDM, using non-inferiority margin delta = 0.05. The reader will first record whether there are mammographic findings and an initial BI-RADS assessment of 0, 1, or 2. If the answer to this question is "no" the reader will be asked to confirm for this case: a BI-RADS assessment category of 1 or 2, a Probability of Malignancy (POM) score following the POM guidance provided in the protocol, and recall decision of "no". If the reader answers "yes" to whether there are mammographic findings, the reader will be asked to confirm an initial BI-RADS assessment category of 0, and will then provide detailed information on each suspicious finding (up to three findings) and the decision whether or not to recall the subject, as well as overall POM score and BI-RADS assessment category.'}, {'measure': 'Compare Per-subject Average Recall Rate for DBT Plus S-View Versus FFDM for All Cancer Cases', 'timeFrame': '4 weeks', 'description': 'Based on recall rate for all cancer cases for DBT plus S-View versus FFDM, using non-inferiority margin delta = 0.10. The reader will first record whether there are mammographic findings and an initial BI-RADS assessment of 0, 1, or 2. If the answer to this question is "no" the reader will be asked to confirm for this case: a BI-RADS assessment category of 1 or 2, a Probability of Malignancy (POM) score following the POM guidance provided in the protocol, and recall decision of "no". If the reader answers "yes" to whether there are mammographic findings, the reader will be asked to confirm an initial BI-RADS assessment category of 0, and will then provide detailed information on each suspicious finding (up to three findings) and the decision whether or not to recall the subject, as well as overall POM score and BI-RADS assessment category.'}, {'measure': 'Compare Per-subject Average Sensitivity for DBT Plus S-View Versus FFDM', 'timeFrame': 'Four weeks', 'description': 'Based on forced BI-RADS scores requiring correct lesion localization, using non-inferiority margin delta = 0.10. The reader will first record whether there are mammographic findings and an initial BI-RADS assessment of 0, 1, or 2. If the answer to this question is "no" the reader will be asked to confirm for this case: a BI-RADS assessment category of 1 or 2, a Probability of Malignancy (POM) score following the POM guidance provided in the protocol, and recall decision of "no". If the reader answers "yes" to whether there are mammographic findings, the reader will be asked to confirm an initial BI-RADS assessment category of 0, and will then provide detailed information on each suspicious finding (up to three findings) and the decision whether or not to recall the subject, as well as overall POM score and BI-RADS assessment category.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of the pivotal reader study is to assess the comparative accuracy of Fujifilm DBT plus S-View versus FFDM in the detection of breast cancer.', 'detailedDescription': 'This clinical research is a retrospective, pivotal, multi-reader, multi-case (MRMC) study with an enriched sample of 300 breast screening or diagnostic cases which were selected from the library of mammograms collected under Fujifilm protocol FMSU2013-004A (all subjects previously provided written informed consent agreeing their image data and supporting documentation could be used for future research and investigations). Approximately 18 qualified radiologists will independently perform two reads on all (approximately 300) cases. Each reader will read each case both as a FFDM read, and a DBT plus S-View read on the ASPIRE Bellus II workstation.\n\nAs its primary endpoint, this study is designed to evaluate whether the area under the receiver operating characteristic (ROC) curve (AUC) based on probability of malignancy (POM) scores and requiring correct lesion localization is statistically non-inferior for DBT plus S-View versus FFDM.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This is a reader study utilizing retrospectively collected breast images acquired under Fujifilm protocol FMSU2013-004A.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* •Female subjects participating in FMSU2013-004A protocol with known clinical status\n\nExclusion Criteria:\n\n* •Female subjects that did not have known clinical status in FMSU2013-004A'}, 'identificationModule': {'nctId': 'NCT03501693', 'briefTitle': 'Fujifilm DBT Plus S-View Versus FFDM Alone in the Detection of Breast Cancer - A Pivotal Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fujifilm Medical Systems USA, Inc.'}, 'officialTitle': 'A Multi-Reader Multi-Case Controlled Clinical Trial to Evaluate the Comparative Accuracy of the Fujifilm DBT Plus S-View Versus FFDM Alone in the Detection of Breast Cancer - A Pivotal Study', 'orgStudyIdInfo': {'id': 'FMSU2017-002B'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'DBT plus S-View', 'description': 'Breast images utilizing DBT plus S-View', 'interventionNames': ['Device: DBT plus S-View']}, {'label': 'FFDM alone', 'description': 'FFDM alone images', 'interventionNames': ['Device: FFDM Alone']}], 'interventions': [{'name': 'DBT plus S-View', 'type': 'DEVICE', 'description': 'DBT plus S-View images', 'armGroupLabels': ['DBT plus S-View']}, {'name': 'FFDM Alone', 'type': 'DEVICE', 'description': 'FFDM alone images', 'armGroupLabels': ['FFDM alone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06851', 'city': 'Norwalk', 'state': 'Connecticut', 'country': 'United States', 'facility': 'International HealthCare, LLC', 'geoPoint': {'lat': 41.1176, 'lon': -73.4079}}], 'overallOfficials': [{'name': 'Robert M Uzenoff', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Fujifilm Medical Systems USA, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fujifilm Medical Systems USA, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}