Study of 3D Automated Breast Ultrasound Imaging Using the ATUSA System for Women with Suspicious Breast Findings Scheduled for Biopsy

What this Trial Is About

Researchers are evaluating the use of the ATUSA 3D Automated Breast Ultrasound system in women who have suspicious breast findings classified as BI-RADS 4 or 5 and are referred for biopsy. This observational study aims to gather detailed breast imaging data alongside biopsy results to create a comprehensive registry. The study also follows a subset of participants receiving neoadjuvant therapy to monitor treatment response and tumor volume changes. The study uses the FDA-cleared ATUSA device, which includes a portable ultrasound scanner, a wearable positioning accessory, and software to acquire 3D breast images. Imaging with this system is performed for data collection only and does not influence clinical care, which proceeds according to standard practice. The registry collects multimodal breast images and medical record information over the study period. Participants will undergo ATUSA imaging and other breast imaging exams, with data collected from enrollment through approximately 180 days. Satisfaction questionnaires are completed on the day of ATUSA imaging. Researchers will track the number and types of imaging exams, participant and operator satisfaction, and any adverse events related to the ATUSA system. Follow-up includes monitoring for safety events for up to seven days after imaging. The total participation duration varies but includes imaging and data collection over several months.

ATUSA Ultrasound Diagnostic Imaging for Breast Lesions Evaluation (AUDIBLE)