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 because the information has not been verified recently.
Verified March 2012 by Rose Imaging Specialists, P.A..
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Hologic, Inc.
Information provided by (Responsible Party):
Rose Imaging Specialists, P.A.
ClinicalTrials.gov Identifier:
NCT01569802
First received: March 29, 2012
Last updated: March 30, 2012
Last verified: March 2012
  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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 10000
Study Start Date: January 2012

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Rose Imaging Specialists, P.A.
ClinicalTrials.gov Identifier: NCT01569802     History of Changes
Other Study ID Numbers: 11-02
Study First Received: March 29, 2012
Last Updated: March 30, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 24, 2014