Detection and/or Evaluation of Dense Breast Abnormalities Using Tomosynthesis and Digital Mammography
Early Phase 1
Completed
- Conditions
- Breast AbnormalitiesBreast Neoplasms
- Interventions
- Procedure: Breast Tomosynthesis
- Registration Number
- NCT00722059
- Lead Sponsor
- University of Michigan
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 50
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Breast Tomosynthesis Subjects will undergo a 3D breast Tomosynthesis imaging scan. This is a one time breast imaging scan will last approximately 15 minutes.
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Michigan Health System
🇺🇸Ann Arbor, Michigan, United States