Breast Mass
Conditions
Brief summary
The purpose of this study is to determine the efficacy of targeted breast ultrasound ("ultrasound in the grid") performed concurrently with diagnostic mammogram during breast compression with an open mammogram paddle in lesion detection when compared to standard diagnostic breast ultrasound. Open paddle spot tomosynthesis and ultrasound in the grid images will be compared to the standard of care, and outcome measures will include comparing accuracy of lesion detection with the new technique versus the standard of care and differences in time to acquire the images for the new technique versus the current standard of care. Radiologists will also review the different sets of images and give confidence scores of lesion correspondence between mammogram and ultrasound. This will be a pilot study of 25 patients to demonstrate proof of concept and is intended to lay the foundation for future funded research with a larger patient population.
Interventions
DIAGNOSTIC_TESTTargeted ultrasound in the grid
Patients will have a single spot tomosynthesis mammogram image performed with an open compression paddle and concurrent targeted ultrasound imaging of the breast tissue contained in the open mammogram paddle while the breast is in compression.
Sponsors
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Mass visible on both diagnostic mammogram and ultrasound * Mass within the size limit to be completely confined within an open grid mammogram paddle (less than 3 cm)
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of breast masses detected | Single visit, up to approximately one hour | The primary outcome will be whether breast masses can be detected using an open mammogram spot tomosynthesis compression paddle and targeted ultrasound in the grid using the experimental technique. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to acquire images | Single visit, up to approximately one hour | The total amount of time to acquire the experimental images (spot tomosynthesis mammogram view with open paddle and targeted ultrasound of breast tissue within the open compression grid). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOREun L Langman, MD
Duke Health
Outcome results
None listed