NCT07471672

Spot Compression Ultrasound Compared to Traditional Breast Ultrasound

Efficacy of Spot Compression Ultrasound Compared to Traditional Breast Ultrasound

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Duke University · Academic / Other
• Sex: Female
• Age: 30 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Mass

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Targeted 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.

Timeline

• Start date: 2026-04-06
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2026-03-13
• Last updated: 2026-03-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study