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

NCT07427407 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-02-24

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

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.

Sponsors & Collaborators

  • AURA Health Technologies

    lead INDUSTRY

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2027-11-30
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07427407 on ClinicalTrials.gov