Breast Computed Tomography (CT) as a Diagnostic Tool
The American Cancer Society has recommended that all women over the age of 40 have an annual mammogram for many years. This recommendation has been associated with a substantial decrease in breast cancer deaths. When something suspicious is seen in one of these mammograms, the woman is called back to the clinic for more imaging tests to better determine if that suspicious feature might be breast cancer. These additional imaging tests include repeated mammograms, magnification mammograms and/or ultrasound. Depending on what is seen in these images, the radiologist will provide a diagnosis that the suspicion is probably cancer, probably benign, or that the suspicion is a "false alarm." If it is a false alarm, then the woman is sent home and she should come back after a year for another standard annual mammogram. If the diagnosis is that it is probably benign, then the woman should come back after 6 months so that the suspicion can be tested again. If the diagnosis is that it is probably cancer, the woman is recommended to have a biopsy so that the cancer can be confirmed. Both fortunately and unfortunately, 80% of the biopsies turn out to be "false alarms." Although confirming that a woman does not have cancer is always a very good thing, having put her through the anxiety, expense, and risk of a biopsy for what turned out to be nothing should be avoided. Therefore, it would be desirable to reduce the number of unnecessary biopsies that are performed.
Dedicated breast computed tomography (or breast CT), a new way of imaging the breast, has been introduced in the last few years. Breast CT is an x-ray exam that uses 3D imaging to show the breast in its real three dimensional shape. The investigators propose to use breast CT as a new, better tool for the radiologist to perform the diagnosis, and therefore hopefully result in fewer biopsies, which should decrease the "false alarms." Before breast CT can be used clinically as a diagnostic tool, extensive testing must be performed. In this first step, the investigators propose to acquire breast CT images of only 10 patients that have been recommended to have biopsies, to see if the radiologist would have arrived at a different diagnosis if he/she had based his/her decision on the breast CT images. Since this has never been attempted before, this is an initial small study to test the feasibility of this method.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Breast CT as a Diagnostic Tool|
- Reduction in negative biopsies [ Time Frame: After biopsy ] [ Designated as safety issue: No ]
|Study Start Date:||May 2009|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
See Brief Summary
Please refer to this study by its ClinicalTrials.gov identifier: NCT00957307
|United States, Georgia|
|Emory University Hospital Breast Imaging Center|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Ioannis Sechopoulos, PhD||Emory University|