Prospective Ultrasound Data Collection Study for AI-Based Detection of Breast Biopsy Markers
Starting soon
Conditions studied: Breast Cancer
In brief
The goal of this observational study is to collect ultrasound imaging data to support the development and refinement of an artificial intelligence (AI)-enhanced ultrasound software designed to detect and localize standard-of-care breast biopsy markers in adult female patients undergoing surgical excision of a breast tumor. The main questions it aims to answer are: Can the study software identify the location of previously placed breast biopsy markers during routine ultrasound examinations? Participants will undergo limited breast ultrasound imaging during a standard-of-care scheduled clinical visit. During the ultrasound imaging, the ultrasound system will automatically record the ultrasound images for the development and training of the AI software The study does not change standard medical care, and no diagnostic or treatment decisions are made based on the study software.
Key facts
- Study ID
- NCT07427407
- Run by
- AURA Health Technologies
- People needed
- 100
- Starts
- 2026-05-01
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-02-24
Who can join
Age: 21 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Participant can understand and sign informed consent documentation
- Participant has a previous placement of one of the standard-of-care breast biopsy markers
You may not qualify if…
- Previous breast cancer surgery in the region of interest
- Life expectancy <6 months
- Allergy and/or hypersensitivity to titanium and/or nickel and/or ultrasound gel
- Carcinoma unknown primary
- Patient does not accept ultrasound examinations
- Patient with skin disease of areas to be examined (breast and/or axillary)
Where it is running
- Columbia University Irving Medical Center — New York, New York, United States
Full record on ClinicalTrials.gov
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