Fujifilm DBT Plus S-View Versus FFDM Alone in the Detection of Breast Cancer - A Pivotal Study
NCT ID: NCT03501693
Last Updated: 2023-09-21
Study Results
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View full resultsBasic Information
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COMPLETED
300 participants
OBSERVATIONAL
2018-04-06
2018-08-31
Brief Summary
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Detailed Description
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As 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.
Conditions
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Study Design
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CASE_CROSSOVER
RETROSPECTIVE
Study Groups
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DBT plus S-View
Breast images utilizing DBT plus S-View
DBT plus S-View
DBT plus S-View images
FFDM alone
FFDM alone images
FFDM Alone
FFDM alone images
Interventions
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DBT plus S-View
DBT plus S-View images
FFDM Alone
FFDM alone images
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
FEMALE
Yes
Sponsors
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Fujifilm Medical Systems USA, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Robert M Uzenoff
Role: STUDY_DIRECTOR
Fujifilm Medical Systems USA, Inc.
Locations
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International HealthCare, LLC
Norwalk, Connecticut, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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FMSU2017-002B
Identifier Type: -
Identifier Source: org_study_id
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