Assessment of Digital Breast Tomosynthesis (DBT) in the Screening Environment: a Prospective Study
35 Years
55 Years
Female
Breast Abnormalities
Trial Information
Assessment of Digital Breast Tomosynthesis (DBT) in the Screening Environment: a Prospective Study
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.
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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
recall rates
Outcome Description:
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.
Outcome Time Frame:
upon recruitment/enrollment phase completion
Safety Issue:
No
Principal Investigator
Jules H Sumkin, DO
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Pittsburgh
Authority:
United States: Institutional Review Board
Study ID:
PRO09060334
NCT ID:
NCT01106911
Start Date:
May 2010
Completion Date:
Related Keywords:
- Breast Abnormalities
- digital breast tomosynthesis
- baseline screening mammography
- recall rates
- Congenital Abnormalities
Name | Location |
|---|---|
| Magee-Womens Hospital | Pittsburgh, Pennsylvania 15213-3180 |
