ATUSA Ultrasound Diagnostic Imaging for Breast Lesions Evaluation (AUDIBLE)

Part of paid clinical trials in Sacramento, California.

Sponsor: iSono Health, Inc.
Study ID: NCT07505797
Status: Recruiting

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Conditions

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

Eligibility Criteria

Sex: FEMALE
Age: 18 Years - 94 Years
Healthy Volunteers: Not accepted

Interventions

ATUSA 3D Automated Breast Ultrasound System — DEVICE
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.

Study Details

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.