Fibrocystic Disease of Breast, Breast Cancer
Conditions
Keywords
Breast Cancer, Mammography, Benign masses, Breast Lump, Breast Biopsy, Breast Mass
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.
Interventions
Women with a positive screening mammogram called back for additional views will be asked to undergo an additional Digital Breast Tomosynthesis (3D mammogram) on the affected breast. Radiation dose is somewhat less than that of a screening mammogram.
Sponsors
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed