Spot Compression Ultrasound Compared to Traditional Breast Ultrasound

Duke University

Status: Begins enrollment this month

Conditions: Breast Mass

Treatments: Diagnostic Test: Targeted ultrasound in the grid

Study type: Interventional

Funder types: Other

Identifiers

NCT07471672

Pro00111770

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: Female

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Spot Compression Ultrasound

Experimental group

Description:

This arm includes all participants enrolled in the study who will receive the experimental imaging technique

Treatment:

Diagnostic Test: Targeted ultrasound in the grid