Prospective Chart-Review: Impact of Combination - Digital Breast Tomosynthesis + Digital Mammography
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/18/2012 |
| Start Date: | April 2012 |
To Determine the Clinical Impact of the Combination of Digital Breast Tomosynthesis and Digital Mammography on Screening for Breast Cancer
Digital Breast Tomosynthesis (DBT) is a technology that has been developed to improve lesion
detection in dense breasted women. Even though DBT has been regarded as a study for dense
breasted women, it may also improve lesion detection at an earlier stage and smaller size in
women with less dense breast tissue. The overlapping of tissue on a standard of care 2D
mammogram leads to decreased cancer detection, it also contributes to pseudo lesions that
mimic cancers. This leads to patients being asked to come back for additional imaging
including mammogram and/or ultrasound images. DBT has shown to decrease call back rates by
up to 43% in reader studies. Even though these results are promising they were not done in a
realistic clinical setting.The purpose of this study is to evaluate the FDA-approved
combination standard digital mammography (DM) and DBT technology and its impact on our
clinical practice.
The investigators would like to prospectively measure the impact on recall rates, comparing
DM (digital mammography) and DM+DBT, in our practice and the impact on cancer detection in
our screening population. This is a two-site study in which all asymptomatic subjects
undergoing the FDA-approved combination standard of care Digital Mammogram and Digital
Breast Tomosynthesis (DM+DBT) exam will be eligible for the trial. Each subject will be her
own control.Only radiologists who have gone through 8 hours of Tomosynthesis training will
interpret the DM and DBT images. These radiologists will categorize each case as either
dense (BI-RADS density score of 3 or 4) or fatty (BI-RADS density score of 1 or 2). The
radiologist will initially read the standard of care DM part of the study first and record
their interpretation and final BIRADs category. The same radiologist will then interpret the
DM+DBT combination study and record their final interpretation and BIRADs category. Prior
mammogram studies will be used for comparison when reading the DM and DM+DBT studies.
Inclusion Criteria:
- Female ages 30 and over
- Asymptomatic
- Any ethnic origin
- No contraindication for routine bilateral mammogram
Exclusion Criteria:
- Pregnancy
- Lactating patients
- Breast implants
- Unable to understand and execute written informed consent
- Patient unable to obtain a mammogram while standing without assistance
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Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center We all know...
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