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Assessment of Digital Breast Tomosynthesis (DBT) in the Screening Environment: a Prospective Study

35 Years
55 Years
Open (Enrolling)
Breast Abnormalities

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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:


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:


Principal Investigator

Jules H Sumkin, DO

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh


United States: Institutional Review Board

Study ID:




Start Date:

May 2010

Completion Date:

Related Keywords:

  • Breast Abnormalities
  • digital breast tomosynthesis
  • baseline screening mammography
  • recall rates
  • Congenital Abnormalities



Magee-Womens Hospital Pittsburgh, Pennsylvania  15213-3180