Clinical Trial

Prospective Ultrasound Data Collection Study for AI-Based Detection of Breast Biopsy Markers

Not Yet Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-02-17.
Trial Details
NCT Number NCT07427407
Lead Sponsor AURA Health Technologies
Conditions Breast Cancer
Enrollment 100 participants
Start Date 2026-05
Primary Completion 2027-11 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-02-24