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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jules Sumkin, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01106911
First received: April 16, 2010
Last updated: February 24, 2016
Last verified: February 2016

April 16, 2010
February 24, 2016
May 2010
September 2014   (final data collection date for primary outcome measure)
Number of Participants Without Cancer Who Were Recalled [ Time Frame: upon recruitment/enrollment phase completion ] [ Designated as safety issue: No ]
Recall rates of digital breast tomosynthesis and full field digital mammography in younger women undergoing their initial screening mammogram will be assessed and compared.
recall rates [ Time Frame: upon recruitment/enrollment phase completion ] [ Designated as safety issue: No ]
Recall rates and specificity of digital breast tomosynthesis and full field digital mammography in younger women undergoing their initial screening mammogram will be assessed and compared.
Complete list of historical versions of study NCT01106911 on ClinicalTrials.gov Archive Site
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Assessment of Digital Breast Tomosynthesis (DBT) in the Screening Environment
Assessment of Digital Breast Tomosynthesis (DBT) in the Screening Environment: a Prospective Study
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%.
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.
Interventional
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Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Breast Abnormalities
Device: tomosynthesis and screening mammography
All eligible subjects will undergo both full field digital mammography and digital breast tomosynthesis.
Other Name: digital breast tomosynthesis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1080
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September 2014   (final data collection date for primary outcome measure)

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
Female
35 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01106911
PRO09060334
No
Not Provided
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Jules Sumkin, University of Pittsburgh
University of Pittsburgh
Not Provided
Principal Investigator: Jules H Sumkin, DO University of Pittsburgh
University of Pittsburgh
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP