Assessment of Emerging Technology: Comparison of Breast Tomosynthesis and Digital Mammography in the Evaluation of Heterogeneously Dense and Extremely Dense Breasts
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- University of Michigan
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Measure of digital tomosynthesis and digital mammography test performance.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts 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.
Arms & Interventions
1
Subjects will undergo a 3D breast Tomosynthesis imaging scan. This is a one time breast imaging scan will last approximately 15 minutes.
Intervention: Breast Tomosynthesis (Procedure)
Outcomes
Primary Outcomes
Measure of digital tomosynthesis and digital mammography test performance.
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Alexis V. Nees M.D.
Principal Investigator
University of Michigan