Study of High-resolution, Lower Dose Dedicated Breast CT.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- University of Arizona
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- Diagnostic accuracy
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
Brief Summary
This study is being performed to find out if a new kind of breast imaging (called dedicated breast CT or BCT) can help doctors to see the small structures in breast tissue more clearly. The investigators also want to find out if using the BCT will provide a more accurate diagnosis of breast cancer.
Detailed Description
The breast imaging device that will be used in this study (breast computed tomography or BCT) is not FDA-approved for this use so this is a research study. The machine has been redesigned to see if doctors can see smaller structures and use a lower radiation dose. The breast CT device will take multiple pictures of the subject's breast and create a 3-D image of the breast. It does not compress or squash the breast like a mammogram.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Diagnostic accuracy
Time Frame: 12 months after completion of accrual
The diagnostic accuracy of BCT will be determined from a multi-reader, multi-case reader study.