A Comparison of Recall Rates Between Conventional 2d Mammography and 2d Plus 3d (Tomosynthesis) Mammography in a Screening Population

NCT ID: NCT01569802

Last Updated: 2012-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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screening

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hologic, Inc.

INDUSTRY

Sponsor Role collaborator

Rose Imaging Specialists, P.A.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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TOPS

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Andra Tidwell, RT(R)(M)

Role: primary

281-580-6171

Other Identifiers

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11-02

Identifier Type: -

Identifier Source: org_study_id

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