Spot Compression Ultrasound Compared to Traditional Breast Ultrasound

NCT07471672 | Not Yet Recruiting FDA Device

• 1 other identifier: Pro00111770
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Number of breast masses detected

  The primary outcome will be whether breast masses can be detected using an open mammogram spot tomosynthesis compression paddle and targeted ultrasound in the grid using the experimental technique.

  Single visit, up to approximately one hour

Secondary Outcomes (1)

• Time to acquire images

  Single visit, up to approximately one hour

Study Arms (1)

Spot Compression Ultrasound

EXPERIMENTAL

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

Diagnostic Test: Targeted ultrasound in the grid

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.

Also known as: Spot tomosynthesis mammogram

Spot Compression Ultrasound

Eligibility Criteria

• Age: 30 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• None

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Cancer Center

Durham, North Carolina, 27710, United States

Location

Study Officials

• Eun L Langman, MD

  Duke Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eun L Langman, MD

CONTACT

919-684-2711; eun.langman@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 13, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: July 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)