A Comparison of Breast Tomosynthesis Mammography and Conventional Breast Imaging in the Characterization of Breast Masses
Early Phase 1
Completed
- Conditions
- Breast CancerFibrocystic Disease of Breast
- Interventions
- Device: Digital Breast Tomosynthesis
- Registration Number
- NCT00826488
- Lead Sponsor
- Washington University School of Medicine
- Brief Summary
The purpose of this study is to compare conventional breast imaging and diagnostic work-up (2 dimensional imaging) to digital breast tomosynthesis (3 dimensional imaging) in the appearance of non-calcified breast masses. It is thought that non-calcified breast masses will be better visualized with the new 3D technology.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 136
Inclusion Criteria
- Female
- Any race or ethnicity
- At least 35 years old
- Prior screening or full diagnostic mammogram at Barnes Jewish Breast Health Center
Exclusion Criteria
- Unable or unwilling to undergo informed consent
- Subjects who have breast implants
- Subjects who are unable or unwilling to tolerate compression
- Subjects who are pregnant or who think they may be pregnant
- Subjects who are currently lactating
- Men
- Women less than 35 years old
- Women greater than 80 years old
- Subjects whose breasts are larger than the tomosynthesis detector
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description observational Digital Breast Tomosynthesis Observational
- Primary Outcome Measures
Name Time Method It is anticipated that out of 100 subjects recalled for additional breast imaging that 10 women will be recalled for biopsy. By adding 2D & 3D imaging, it is anticipated that 30 subjects out of 100 will have needed no workup. 9 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
JoAnne Knight Breast Center, Barnes Hospital
🇺🇸St. Louis, Missouri, United States