Recruiting

Mammography Comparison

Sponsor:

Rose Imaging Specialists, P.A.

Code:

NCT01569802

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 30+

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Breast Cancer

Study ID

NCT01569802

Start date

Jan, 2012

Status verified date

Mar, 2012

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 30+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

10000 participants

Anticipated

Interventions and Outcome Measures

Arms

screening

Primary outcome measure

  • Recall Rate [ Time Frame: up to 1 year ]

Central Contacts and Locations

Locations

TOPS

Recruiting

Houston, Texas, United States, 77090

Contacts

Andra Tidwell, RT(R)(M)

281-580-6171atidwell@uspi.com

More Information

Sponsor

Rose Imaging Specialists, P.A.

Last update posted

Apr 3, 2012

Last verified

Mar, 2012

Keywords

  • breast cancer screening
  • tomosynthesis
  • FFDM

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rose Imaging Specialists, P.A. on 2012-04-03.