A Multi-Center Clinical Study to Acquire Xpress Digital Mammography System Images for Computer Aided Detection Development

Trial Information

A Multi-Center Clinical Study to Acquire 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.