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

University of Pittsburgh1,080 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

1,080

Conditions

Breast Abnormalities

Interventions

tomosynthesis and screening mammographyDEVICE

All eligible subjects will undergo both full field digital mammography and digital breast tomosynthesis.

Eligibility

Sex: FEMALEMin age: 35 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Magee-Womens Hospital

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

Number of Participants Without Cancer Who Were Recalled

Recall rates of digital breast tomosynthesis and full field digital mammography in younger women undergoing their initial screening mammogram will be assessed and compared.

Time frame: upon recruitment/enrollment phase completion

Data from ClinicalTrials.gov

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