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NCT Number: NCT07471672

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.

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Key information

Conditions

Age range

30 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Cancer Center

Durham, North Carolina, 27710, United States

Location contact

Eun L Langman, MD

CONTACT

[email protected]

919-684-2711

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Spot tomosynthesis mammogram

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Eun L Langman, MD

CONTACT

[email protected]

919-684-2711

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Efficacy of Spot Compression Ultrasound Compared to Traditional Breast Ultrasound

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 13, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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