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

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ClinicalTrials.gov Identifier: NCT01569802
Recruitment Status : Unknown
Verified March 2012 by Rose Imaging Specialists, P.A..
Recruitment status was:  Recruiting
First Posted : April 3, 2012
Last Update Posted : April 3, 2012
Sponsor:
Collaborator:
Hologic, Inc.
Information provided by (Responsible Party):
Rose Imaging Specialists, P.A.

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.

Condition or disease
Breast Cancer

Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Comparison of Recall Rates Between Conventional 2d Mammography and 2d Plus 3d (Tomosynthesis) Mammography in a Screening Population
Study Start Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mammography
U.S. FDA Resources

Group/Cohort
screening



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Cancer detection Rate [ Time Frame: up to 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
radiology clinic screening population
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01569802


Locations
United States, Texas
TOPS Recruiting
Houston, Texas, United States, 77090
Contact: Andra Tidwell, RT(R)(M)    281-580-6171    atidwell@uspi.com   
Sponsors and Collaborators
Rose Imaging Specialists, P.A.
Hologic, Inc.

Responsible Party: Rose Imaging Specialists, P.A.
ClinicalTrials.gov Identifier: NCT01569802     History of Changes
Other Study ID Numbers: 11-02
First Posted: April 3, 2012    Key Record Dates
Last Update Posted: April 3, 2012
Last Verified: March 2012

Keywords provided by Rose Imaging Specialists, P.A.:
breast cancer screening
tomosynthesis
FFDM