Spot Compression Ultrasound Compared to Traditional Breast Ultrasound

Conditions

• Breast Mass

Eligibility Criteria

Sex

FEMALE

Age

30 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Targeted ultrasound in the grid — DIAGNOSTIC_TEST
  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.

Study Details

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.

Key Dates

First listed

Mar 13, 2026

Start date

Jul 31, 2026

Status verified

Mar 2026

Primary completion

Oct 1, 2026

Completion

Oct 1, 2026

Study Design

Enrollment

25 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Arms

• Experimental: Spot Compression Ultrasound
  This arm includes all participants enrolled in the study who will receive the experimental imaging technique

Primary Outcome Measure

Number of breast masses detected [ Time Frame: Single visit, up to approximately one hour ]

Locations (1)

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