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Assessment of Digital Breast Tomosynthesis (DBT) in the Screening Environment

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ClinicalTrials.gov Identifier: NCT01106911
Recruitment Status : Completed
First Posted : April 20, 2010
Results First Posted : March 25, 2016
Last Update Posted : March 25, 2016
Sponsor:
Information provided by (Responsible Party):
Jules Sumkin, University of Pittsburgh

Study Description
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Brief Summary:
The objective of this study is to demonstrate that digital breast tomosynthesis (DBT) in combination with full field digital mammography (FFDM) has the potential to reduce significantly baseline screening recall rates without a loss in the detection of cancers. The primary hypothesis of the study is that DBT in combination with FFDM will reduce baseline screening mammography recall rates in negative examinations by at least 20%.

Condition or disease Intervention/treatment Phase
Breast Abnormalities Device: tomosynthesis and screening mammography Not Applicable

Detailed Description:
The FFDM images and the FFDM images with the DBT images will be interpreted independently by two experienced radiologists under standard clinical screening procedures. Recommended recall rates will be assessed and compared as a result of each of the two interpretations.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1080 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Assessment of Digital Breast Tomosynthesis (DBT) in the Screening Environment: a Prospective Study
Study Start Date : May 2010
Actual Primary Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mammography

Arms and Interventions
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Intervention Details:
  • Device: tomosynthesis and screening mammography
    All eligible subjects will undergo both full field digital mammography and digital breast tomosynthesis.
    Other Name: digital breast tomosynthesis

Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants Without Cancer Who Were Recalled [ Time Frame: upon recruitment/enrollment phase completion ]
    Recall rates of digital breast tomosynthesis and full field digital mammography in younger women undergoing their initial screening mammogram will be assessed and compared.


Eligibility Criteria
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Ages Eligible for Study:   35 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women between the ages of 34 and 56.
  • Women presenting for their baseline screening mammography examination

Exclusion Criteria:

  • Women with a palpable finding(s) via a Breast Self Examination (BSE) or Clinical Breast Examination (CBE).
  • Women who may be or are pregnant by self report
  • Women older than 55 years of age or younger than 35.
  • Women with known fatty breast tissue
  • Males and children
  • Women who are unable to understand or execute written informed consent
Contacts and Locations
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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): NCT01106911


Locations
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United States, Pennsylvania
Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
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Principal Investigator: Jules H Sumkin, DO University of Pittsburgh
More Information
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Responsible Party: Jules Sumkin, Chief of Women's Imaging, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01106911    
Other Study ID Numbers: PRO09060334
First Posted: April 20, 2010    Key Record Dates
Results First Posted: March 25, 2016
Last Update Posted: March 25, 2016
Last Verified: February 2016
Keywords provided by Jules Sumkin, University of Pittsburgh:
digital breast tomosynthesis
baseline screening mammography
recall rates
Additional relevant MeSH terms:
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Congenital Abnormalities