ATUSA Ultrasound Diagnostic Imaging for Breast Lesions Evaluation (AUDIBLE)

ATUSA Ultrasound Diagnostic Imaging for Breast Lesions Evaluation (AUDIBLE), a Case Collection Registry for 3D Breast Automated Ultrasound Using ATUSA System as Well as Other Breast Imaging Modalities.

AUDIBLE is a multi-site, clinical study conducted in the United States aimed at gathering data on 3D Automated Breast Ultrasound imaging using the iSono Health ATUSA system. The study focuses on female participants who have previously been identified with suspicious findings (classified as BIRADs 4 or 5) through standard-of-care diagnostic imaging methods (e.g., hand-held ultrasound, mammograms) and who have been referred for a biopsy. The goal is to create a comprehensive registry that includes multi-modality breast images alongside and biopsy results. The study will enroll up to 800 eligible female patients. In addition to imaging data, the study will collect information from the patient's medical records and biopsy outcomes.

The study aims to validate ATUSA's image quality, reproducibility, and correlation with histopathology and radiologist-assigned BI-RADS categories. Additionally, a subset of participants receiving neoadjuvant therapy will be followed longitudinally to evaluate ATUSA's potential for monitoring treatment response and volumetric changes in tumor burden.

This study supports the advancement of a patient-friendly, radiation-free, operator-independent ultrasound platform for real-time breast imaging.

Inclusion Criteria:

1. Provide written informed consent through a signed and dated consent form.
2. Demonstrate commitment to complete all study requirements and maintain availability for the full study duration.
3. Be female, aged 18 to 94 years (inclusive).
4. Have a recent BI-RADS® 4 or 5 classification confirmed through breast imaging and medical records.

Exclusion Criteria:

1. Active skin lesions (open wounds or unhealed sores) on either breast.
2. Implanted medical devices (pacemakers, defibrillators) or MRI incompatible materials that cannot be temporarily removed.
3. Current pregnancy or breastfeeding status (self-reported).Documented hypersensitivity to silicone or gadolinium-based contrast agents.
4. Previous bilateral mastectomy.
5. Physical inability to maintain a supine position for 30 minutes.
6. Breast anatomy incompatible with ATUSA device specifications.
7. Recent (within 12 months) breast surgery or cancer treatment.
8. Negative findings on diagnostic ultrasound examination within 30 days of Screening, but prior to initiating study required procedures.
9. Any medical or psychological condition that, in the Principal Investigator's judgment, could affect study participation or data integrity.