NCT01569802UnknownNot Applicable
A Comparison of Recall Rates Between Conventional 2d Mammography and 2d Plus 3d (Tomosynthesis) Mammography in a Screening Population
Rose Imaging Specialists, P.A.1 site in 1 country10,000 target enrollmentStarted: January 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 10,000
- Locations
- 1
- Primary Endpoint
- Recall Rate
Study Overview
Brief Summary
The primary aim of this study is to measure, document and compare recall rates of two-dimensional plus three dimensional (2D plus 3D) (Tomosynthesis) mammography to that of 2D mammography in a screening population. This study will compare recall rates for both non-cancer and cancer cases.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 30 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Subject is female of any race and ethnicity
- •The subject is asymptomatic and presents for routine screening mammography and chooses to have a combination 2D + 3D mammogram as her standard of care.
Exclusion Criteria
- •Patient chooses standard 2D mammography over a combination 2D + 3D mammogram
Outcomes
Primary Outcomes
Recall Rate
Time Frame: up to 1 year
measure, document and compare recall rates of two-dimensional plus three dimensional (2D plus 3D) (Tomosynthesis) mammography to that of 2D mammography in a screening population
Secondary Outcomes
- Cancer detection Rate(up to 1 year)
Investigators
Study Sites (1)
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