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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01569802

Enrollment

10000

Registered

2012-04-03

Start date

2012-01-31

Completion date

Unknown

Last updated

2012-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

breast cancer screening, tomosynthesis, FFDM

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

30 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Recall Rate	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

Measure	Time frame
Cancer detection Rate	up to 1 year

Countries

United States

Outcome results