Breast Abnormalities, Breast Neoplasms
Conditions
Brief summary
The purpose of this study is to compare 3D mammography with digital mammography in women with dense breasts for the detection and evaluation of masses and/or breast cancer.
Interventions
PROCEDUREBreast Tomosynthesis
3D breast imaging
Sponsors
University of Michigan
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Females 30 years of age or older. * Dense Breasts. * Has undergone clinical two view mammogram and diagnostic breast imaging evaluation. * Suspicious or palpable mass and scheduled for biopsy.
Exclusion criteria
* Pregnant or lactating women. * Prior personal history of breast cancer. * Prior breast augmentation with implants or silicon injection. male patients. * No two view mammogram as part of breast imaging evaluation. * Breast density of almost entirely fatty/scattered fibroglandular densities.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure of digital tomosynthesis and digital mammography test performance. | 3 weeks | Interest of sensitivity, specificity and area under region of concern curve for malignant mass detection. During review, the number of masses and location and size of each mass will be recorded. An additional estimate of probability of malignancy will be recorded for each image sets. |
Countries
United States
Outcome results
None listed