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

This study is currently recruiting participants.
Verified June 2012 by University of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
Jules Sumkin, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01106911
First received: April 16, 2010
Last updated: June 19, 2012
Last verified: June 2012
History of Changes

April 16, 2010
June 19, 2012
May 2010
May 2013   (final data collection date for primary outcome measure)
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.
Same as current
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
Not Provided
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.
 
Recruiting
1080
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May 2013   (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
Yes
Contact: Linda Lovy, RT(R)(M)(CT), RDMS(BR) (412)641-6966 lovyls@upmc.edu
United States
 
NCT01106911
PRO09060334
No
Jules Sumkin, University of Pittsburgh
University of Pittsburgh
Not Provided
Principal Investigator: Jules H Sumkin, DO University of Pittsburgh
University of Pittsburgh
June 2012

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