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Trial record 1 of 1 for:    NCT01569802
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A Comparison of Recall Rates Between Conventional 2d Mammography and 2d Plus 3d (Tomosynthesis) Mammography in a Screening Population

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by Rose Imaging Specialists, P.A..
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01569802
First Posted: April 3, 2012
Last Update Posted: April 3, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Hologic, Inc.
Information provided by (Responsible Party):
Rose Imaging Specialists, P.A.
  Purpose
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
Breast Cancer

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Rose Imaging Specialists, P.A.:

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

Estimated Enrollment: 10000
Study Start Date: January 2012

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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.
  More Information

Responsible Party: Rose Imaging Specialists, P.A.
ClinicalTrials.gov Identifier: NCT01569802     History of Changes
Other Study ID Numbers: 11-02
First Submitted: March 29, 2012
First Posted: April 3, 2012
Last Update Posted: April 3, 2012
Last Verified: March 2012

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