This study, called AUDIBLE, is looking at a new way to image breast tissue using the ATUSA 3D Automated Breast Ultrasound System. It's for women aged 18 to 94 who have recently had suspicious breast imaging results (BI-RADS® 4 or 5, meaning a finding that is suspicious for cancer) and are scheduled for a biopsy. The study aims to collect images from the ATUSA system along with your medical records and biopsy results. The main goal is to see how many different types of breast imaging exams are collected from each participant over about six months. This is an observational study, meaning you won't receive a new treatment, but your existing care will be documented.

Study design

This is an observational study planning to include up to 800 female participants. It is not a randomized study.

What's involved

You would provide written consent and be available for the full study duration. The study will collect breast imaging examinations, information from your medical records, and biopsy outcomes from enrollment to about 180 days later.

Compensation

Not stated in the trial record.

Follow-up

Your breast imaging examinations will be collected from enrollment up to approximately 180 days (about 6 months) after enrollment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.