Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to Mammography

ADAPT program consists of 2 recruitment plans (ADAPT-SCR and ADAPT-BX) followed by an
off-line read of the images and data collected (ADAPT-BIE). This study involves the
comparison of two devices that can identify abnormalities in routine breast screening and
diagnostic mammography. Mammography is usually done with full-field digital mammography
(FFDM), which takes flat, two-dimensional X-ray images of the breast. Doctors use the
two-dimensional images to look for cancers and other abnormal tissue. The purpose of this
study is to learn more about the accuracy of full-field digital mammography devices and a new
mammography device called digital breast tomosynthesis (DBT). DBT is similar to full-field
digital mammography, but can also move around the breast to get X-ray images from different
angles, which provides a three-dimensional view that doctors can use to look for cancers and
abnormal tissue. Subjects will undergo routine imaging with FFDM and will also have a DBT
performed. They will continue with their standard of care treatment as would occur outside of
the study. Based on the results of the FFDM and DBT, the subject's status will be followed-up
with routing imaging at approximately 1 year (10-16 months). If the doctor recommends biopsy
based on the FFDM or DBT, information about the biopsy and cancer determination results will
be collected. Being in this study does not require subjects to have a biopsy that was not
recommended by the doctor for normal medical care.

Inclusion Criteria:

- Women aged 30 years or older (≥30 years old);

- Asymptomatic women scheduled for screening mammography or have completed a screening
mammogram within the past 30 days;

- Mammography completed on a General Electric (GE) GE FFDM system (with craniocaudal
(CC) and mediolateral oblique (MLO) views) at the site or another clinical facility;

- Are able and willing to comply with study procedures;

- Have signed and dated the informed consent form;

- Are either surgically sterile or postmenopausal or, if of childbearing potential, the
possibility of pregnancy is remote based on a documented negative patient history and,
optionally, a negative urine pregnancy test (if subject requests one).

Exclusion Criteria:

- Have been previously included in this study;

- Have a history of breast cancer and are in active treatment. However, subjects with a
prior lumpectomy (> 5 years prior) who receive only routine screening mammography
views can be included;

- Have breasts too large to be adequately positioned on 24 x 31 centimeter (cm) FFDM
digital receptor without anatomical cut off during either FFDM or DBT examination;

- Have participated in (within the prior 30 days) another trial of an investigational
product expected to interfere with study procedures or outcomes;

- Have breast implant(s);

- Have reconstructed breast(s).