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

18 Years
Not Enrolling
Breast Cancer

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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.

Inclusion Criteria

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

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Principal Investigator

Etta Pisano, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical University of South Carolina


United States: Institutional Review Board

Study ID:




Start Date:

February 2010

Completion Date:

October 2012

Related Keywords:

  • Breast Cancer
  • breast cancer
  • screening mammograms
  • breast biopsy
  • Breast Neoplasms



University of Iowa Iowa City, Iowa  52242
Jackson Memorial Hospital Miami, Florida  33136
Waterbury Hospital Waterbury, Connecticut  
Greenville Hospital Systems Greenville, South Carolina  
University of Texas San Antonio San Antonio, Texas