Spot Compression Ultrasound Compared to Traditional Breast Ultrasound

March 10, 2026 updated by: Duke University

Efficacy of 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Spot Compression Ultrasound
This arm includes all participants enrolled in the study who will receive the experimental imaging technique
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.
Other Names:
  • Spot tomosynthesis mammogram

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of breast masses detected
Time Frame: Single visit, up to approximately one hour
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to acquire images
Time Frame: Single visit, up to approximately one hour
The total amount of time to acquire the experimental images (spot tomosynthesis mammogram view with open paddle and targeted ultrasound of breast tissue within the open compression grid).
Single visit, up to approximately one hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Eun L Langman, MD, Duke Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 6, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

March 10, 2026

First Submitted That Met QC Criteria

March 10, 2026

First Posted (Actual)

March 13, 2026

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 10, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • Pro00111770

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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