A Prospective, Non-Interventional, Observational Study to Collect Ultrasound Imaging Data for the Development of an AI-Based Software for the Detection and Visualization of Breast Biopsy Markers
AURA Health Technologies
Summary
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.
Description
Study Design and Setting This is a prospective, non-interventional observational study designed to collect ultrasound imaging data and related metadata to support the development, refinement, and performance characterization of an artificial intelligence (AI)-enhanced ultrasound software intended to detect and localize standard-of-care breast biopsy markers. All ultrasound examinations are performed as part of routine clinical care for patients undergoing evaluation and planned surgical excision of a breast tumor. Study participation does not alter standard imaging protocols, clinical workfl…
Eligibility
- Age range
- 21+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Participant can understand and sign informed consent documentation * Participant has a previous placement of one of the standard-of-care breast biopsy markers Exclusion Criteria: * 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)
Interventions
- DeviceBreast Ultrasound Imaging With Investigational AI Software
An FDA-cleared breast ultrasound system with an AI investigational software used for data collection in this observational study. Use of the device does not alter standard clinical care.
Location
- Columbia University Irving Medical CenterNew York, New York