Spot Compression Ultrasound Compared to Traditional Breast Ultrasound

ConditionBreast Mass
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age30+
SponsorDuke University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Spot Compression UltrasoundExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
Single visit, up to approximately one hour

Secondary outcomes

1

Time to acquire images

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).

Time frame
Single visit, up to approximately one hour

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: