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Life sciences · Observational Study
ClinicalTrials.gov · September 17, 2026
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Observational Study.
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Registry record from ClinicalTrials.gov (NCT07505797). This is a study registration, not published results. Lead sponsor: iSono Health, Inc.. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 800 participants (ESTIMATED). Conditions: Breast Cancer, Benign Breast Condition, Breast Fibroadenoma, Breast Neoplasms, Breast Disease, Breast Cancer Female, Breast Pain, Breast Cancer Invasive, Breast Cancer Detection. Interventions: DEVICE: ATUSA 3D Automated Breast Ultrasound System. Primary outcome measures: Type and Number of breast imaging examinations collected per participant , From Enrollment to +/- 180 days. Brief 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.