N/A
N=1,085
Assessment of Digital Breast Tomosynthesis (DBT) in the Screening Environment
Breast Abnormalities
Bottom Line
View on ClinicalTrials.gov: NCT01106911 ↗Enrolled (actual)
1,085
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Number of Participants Without Cancer Who Were Recalled — 274 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- tomosynthesis and screening mammography (Device)
- Age
- Adult · 35+ yrs
- Sex
- Female
- Sponsor
- University of Pittsburgh
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Without Cancer Who Were Recalled |
274 | — |
Summary
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%.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01106911). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.