Spot Compression Ultrasound Compared to Traditional Breast Ultrasound

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.

NCT Number	NCT07471672
Lead Sponsor	Duke University
Conditions	Breast Mass
Enrollment	25 participants
Start Date	2026-09
Primary Completion	2026-10-01 (estimated)
Study Completion	2026-10-01 (estimated)
Updated on ClinicalTrials.gov	2026-07-17