Breast Cancer
Conditions
Keywords
Breast Cancer, Automated whole breast ultrasound, BI-RADS category 3 lesions
Brief summary
Women with dense breasts (BIRADS 3 or 4) with a BIRADS category 1 or 2 mammogram are asked to participate in a automated volume breast ultrasound scanner. The study evaluates prospectively the changes in recall rate, positive biopsy rate, cancer detection rate when BIRADS category 3 lesions are given a 1 year follow-up recommendation.
Detailed description
Women with dense breasts (BIRADS 3 or 4) with a BIRADS category 1 or 2 mammogram are asked to participate in a automated volume breast ultrasound scanner. If the women agrees to participate and sign informed consent she undergoes an automated whole breast scan. The scan is interpreted independent of the mammogram. Scans are assigned a BIRADS category score of 1, 2, 3,or 0. BIRADS category 3 lesions are reported as no evidence of malignancy and a 1 year follow-up is recommended. BIRADS category 0 lesions are requested to have a hand held ultrasound including elastography. Follow up is then determined by BIRADS score and elastography results of hand held ultrasound. The study evaluates prospectively the changes in recall rate, positive biopsy rate, cancer detection rate when BIRADS category 3 lesions are given a 1 year follow-up recommendation.
Interventions
automated whole breast ultrasound
Sponsors
Study design
Eligibility
Inclusion criteria
* Women age \>18 scheduled for routine screening mammogram. Women with Density 3 or 4 and BIRADS category 1 or mammogram are asked to participate in study
Exclusion criteria
* Inability to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decreased recall rate for screening breast ultrasound while maintaining cancer detection rate | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Increased positive biopsy rate | 3 years |