Breast Screening
Conditions
Keywords
Ultrasound, Digital Breast Tomosynthesis, 14-119
Brief summary
The purpose of this study is to determine whether ultrasound or Digital breast tomosynthesis (DBT) detects more cancers and to compare the types of cancers detected on ultrasound and DBT.
Interventions
PROCEDUREbreast ultrasound
PROCEDUREDBT (Full field digital mammography + tomosynthesis)
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Any women scheduled for screening WBUS and a screening FFDM on the same day or within the following 30 days of each other.
Exclusion criteria
* Age \< 30 years old * Male patients * Patients with any clinical symptoms (palpable mass, nipple discharge, etc) * Patients with known cancer * Patients with any breast surgery or biopsy within 90 days prior to the study * Patients with breast implants * Patients pregnant or lactating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| estimate the cancer detection rates | 2 years | The detection rate of each imaging test is defined as the proportion of patients who are positive on that imaging test who truly have the disease compared to the total number of women screened. A positive imaging test is defined as a test with a recommendation for biopsy (BI-RADS 4 or 5). |
Countries
United States
Outcome results
None listed