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Prospective Ultrasound Data Collection Study for AI-Based Detection of Breast Biopsy Markers
Sponsor: 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.
Official title: 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
Key Details
Gender
FEMALE
Age Range
21 Years - Any
Study Type
OBSERVATIONAL
Enrollment
100
Start Date
2026-05
Completion Date
2027-12
Last Updated
2026-02-24
Healthy Volunteers
No
Conditions
Interventions
Breast 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.
Locations (1)
Columbia University Irving Medical Center
New York, New York, United States