Spot Compression Ultrasound Compared to Traditional Breast Ultrasound
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Targeted ultrasound in the grid.
- Who it may be relevant to
- Registry conditions: Breast Mass. Basic parameters: from 30 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of Spot Compression Ultrasound Compared to Traditional Breast Ultrasound
Overview
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.
Interventions
- 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.
Primary outcome measures
- Number of breast masses detected [Time frame: Single visit, up to approximately one hour]
Secondary outcome measures (1)
- Time to acquire images [Time frame: Single visit, up to approximately one hour]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Duke University Cancer Center — Durham
Identifiers
NCT: NCT07471672 · Pro00111770