Pilot Mammography Reader Study to Assess Breast Cancer Detection in FFDM Plus DBT Versus FFDM Alone
NCT ID: NCT02511730
Last Updated: 2023-09-21
Study Results
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View full resultsBasic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2015-06-30
2015-08-31
Brief Summary
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Detailed Description
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1. the radiologist's performance metrics for the two reading modalities, i.e., "FFDM read on the Aspire Bellus workstation" and "FFDM read in conjunction with DBT read on the Aspire Bellus workstation",;
2. the magnitude and direction of differences between performance metrics for the two modalities; and
3. variance components and correlations that would influence samples sizes and case mix for the subsequent pivotal reader study comparing performance metrics between the two modalities.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
NONE
Study Groups
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FFDM Plus DBT
Breast Images with FFDM and DBT
FFDM Plus DBT
FujiFilm Aspire Cristalle System
FFDM Alone
Breast Images with FFDM alone
FFDM
FujiFilm Aspire Cristalle System
Interventions
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FFDM Plus DBT
FujiFilm Aspire Cristalle System
FFDM
FujiFilm Aspire Cristalle System
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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Scottsdale Medical Imaging, Limited (SMIL)
Scottsdale, Arizona, United States
Elizabeth Wende Breast Care, LLC (EWBC)
Rochester, New York, United States
University of North Carolina - at Chapel Hill
Chapel Hill, North Carolina, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Countries
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Other Identifiers
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FMSU2013-004E
Identifier Type: -
Identifier Source: org_study_id
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