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

University of Pittsburgh

Status

Completed

Conditions

Breast Abnormalities

Treatments

Device: tomosynthesis and screening mammography

Study type

Interventional

Funder types

Other

Identifiers

NCT01106911

PRO09060334

Details and patient eligibility

About

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%.

Full description

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.

Enrollment

1,080 patients

Sex

Female

Ages

35 to 55 years old

Volunteers

Accepts Healthy Volunteers

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