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

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 be recruited from an initially asymptomatic population that
have been referred for clinically indicated breast biopsy based on suspicious breast imaging
results. Subjects will undergo a DBT mammogram prior to biopsy. If FFDM was not performed
within 30 days, subjects will also undergo FFDM prior to biopsy. Results of biopsy(ies) and
histopathology, including lesion characteristics, will be recorded and considered as truth if
positive for cancer status. Subjects with negative or benign histological findings will be
followed for approximately one year (10-16 months) by FFDM and any additional standard of
care practice.

Inclusion Criteria:

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

- Initially asymptomatic women that underwent routine screening FFDM, breast ultrasound
(U/S), breast magnetic resonance imaging (MRI) and/or DBT, followed by diagnostic
work-up showing one of more abnormalities and referred for breast biopsy within of 30
days before study entry;

- Are able and willing to comply with study procedures;

- Have signed and dated the informed consent form;

- Documented as non-pregnant based on the investigator's medical judgment and in
consideration of local clinical practice standards for evidence of non-pregnancy.

Exclusion Criteria:

- Have been previously included in this study;

- Have undergone diagnostic or surgical intervention(s) or procedure(s) on either
breast, including mastectomy and cytopunction, before study-related imaging;

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

- 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).