Early Detection of Breast Cancer Using Tomosynthesis Imaging

The purpose is to develop digital tomosynthesis to improve the detection of breast cancers. The aims are optimizing digital mammography and tomosynthesis acquisition, creating visualization tools, prospective pilot studies to evaluate radiologist performance, and computer-aided detection.

Finding breast cancer early has been shown to improve the chance of survival. Mammography (x-ray imaging of the breast) helps find breast cancer early. Some breast cancers, however, are not seen on mammography, which creates two-dimensional images for the radiologist to see. The goal of this study is to make a breast tomosynthesis or tomosynthesis 3D (three-dimensional) x-ray system by taking x-ray images from many angles. This is similar to a CAT (computerized axial tomography) scan for the breast and can give radiologists 3D information so that they can find breast cancers which might otherwise be hidden from view.

The study will be conducted at Duke University Medical Center. Approximately 350 female subjects already scheduled to undergo screening mammography, diagnostic mammography, or breast biopsy will be enrolled in this clinical study. Informed consent will be acquired by the study coordinator or attending radiologist

Inclusion Criteria:

All Subjects accepted for this clinical study must:

• Be already scheduled to undergo screening mammography, diagnostic mammography, or breast biopsy for standard clinical indications
• Provide written informed consent
• Be able to communicate effectively with clinical study personnel.

Exclusion Criteria:

Subjects with any of the following conditions will be excluded from this clinical study:

• Childbearing potential and subject refuses serum pregnancy test or test result is positive.