Xpress Digital Mammography System Images for Computer Aided Detection Development

The proposed study is an image acquisition study of mammograms produced by the investigational digital system. Women who meet the selection criteria and who agree to participate in the study will be imaged with the Xpress Digital Mammography System at the clinical sites. These images will be provided to CAD development companies to conduct their own development and testing. The CAD development companies will be responsible for submitting their results to the FDA for marketing approval of their CAD systems.

Patients will be drawn primarily from those women scheduled for breast biopsy since this population has an enhanced probability of cancer. The intent is to enroll patients until at least 107 women with biopsy proven cancers, and at least 330 women who have negative mammograms are enrolled. All cancers found will be used in the study. It is anticipated that approximately 720 patients undergoing diagnostic mammography will need to be enrolled to yield 107 proven cancer cases. In addition, approximately 330 cases will be drawn from a screening population. The negative status of the screening cases will be established by selecting only cases classified as BIRADS 1 or 2, and have a negative mammogram at one year follow-up. All images collected will be utilized to develop and test the CAD systems, and may be used for further product development.

Inclusion criteria

Cases selected for the study must meet all of the following criteria:

• Female
• Scheduled for a routine screening mammography or routine breast biopsy for non-palpable findings
• Any ethnic origin

Exclusion criteria

Patients meeting any of the following criteria will be excluded from the study:

• Any contraindication to mammography
• Pregnant or suspicion of being pregnant, or nursing
• Patients with palpable lesions
• Patients with internal breast markers in the region of interest
• Breast implants, without displaced views
• Significant recent breast trauma/acute mastitis
• Patient has previously undergone an excisional breast biopsy
• Patients with a history of breast cancer
• Unable or unwilling to give consent