Spot Compression Ultrasound Compared to Traditional Breast Ultrasound

ConditionBreast Mass
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age30+
SponsorDuke University

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Targeted ultrasound in the grid

Treatment groups

25 Participants
are divided into 1 treatment group

Sponsors and collaborators