NCT07505797

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.

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 800 (estimated)
• Sponsor: iSono Health, Inc. · Industry
• Sex: Female
• Age: 18 Years – 94 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Breast Cancer
• Benign Breast Condition
• Breast Fibroadenoma
• Breast Neoplasms
• Breast Disease
• Breast Cancer Female
• Breast Pain
• Breast Cancer Invasive

Interventions

Type	Name	Description
DEVICE	ATUSA 3D Automated Breast Ultrasound System	The ATUSA system is an FDA-cleared Class II automated breast ultrasound device used in this study for investigational data collection purposes only. The device consists of a portable automated ultrasound scanner, a wearable positioning accessory, disposable components, and associated software that acquires three-dimensional ultrasound images of the breast. In this observational registry study, ATUSA imaging is performed to collect multimodality breast imaging data and is not used to guide clinical diagnosis, treatment decisions, or patient management. All clinical assessments and care, including biopsy and diagnostic interpretation, are performed according to standard of care.

Timeline

• Start date: 2025-12-16
• Primary completion: 2026-11-15
• Completion: 2026-12-31
• First posted: 2026-04-01
• Last updated: 2026-04-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study