Prospective Ultrasound Data Collection Study for AI-Based Detection of Breast Biopsy Markers (NCT07427407)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Columbia University Irving Medical Center — New York, New York
Age range: 21 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Columbia University Irving Medical Center — New York, New York
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.