Assessment of Digital Breast Tomosynthesis (DBT) in the Screening Environment
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Women's Studies |
| Therapuetic Areas: | Oncology, Reproductive |
| Healthy: | No |
| Age Range: | 35 - 55 |
| Updated: | 4/21/2016 |
| Start Date: | May 2010 |
Assessment of Digital Breast Tomosynthesis (DBT) in the Screening Environment: a Prospective Study
The objective of this study is to demonstrate that digital breast tomosynthesis (DBT) in
combination with full field digital mammography (FFDM) has the potential to reduce
significantly baseline screening recall rates without a loss in the detection of cancers.
The primary hypothesis of the study is that DBT in combination with FFDM will reduce
baseline screening mammography recall rates in negative examinations by at least 20%.
combination with full field digital mammography (FFDM) has the potential to reduce
significantly baseline screening recall rates without a loss in the detection of cancers.
The primary hypothesis of the study is that DBT in combination with FFDM will reduce
baseline screening mammography recall rates in negative examinations by at least 20%.
The FFDM images and the FFDM images with the DBT images will be interpreted independently by
two experienced radiologists under standard clinical screening procedures. Recommended
recall rates will be assessed and compared as a result of each of the two interpretations.
two experienced radiologists under standard clinical screening procedures. Recommended
recall rates will be assessed and compared as a result of each of the two interpretations.
Inclusion Criteria:
- Women between the ages of 34 and 56.
- Women presenting for their baseline screening mammography examination
Exclusion Criteria:
- Women with a palpable finding(s) via a Breast Self Examination (BSE) or Clinical
Breast Examination (CBE).
- Women who may be or are pregnant by self report
- Women older than 55 years of age or younger than 35.
- Women with known fatty breast tissue
- Males and children
- Women who are unable to understand or execute written informed consent
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