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ATUSA Ultrasound Diagnostic Imaging for Breast Lesions Evaluation (AUDIBLE) - iSono Health

Recruitingn/aAges 18 Years - 94 YearsFemaleiSono Health, Inc.
NCT07505797 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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,

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📋 Eligibility rules (as published)
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.
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What it tests

  • ATUSA 3D Automated Breast Ultrasound System
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Where

2 sites
UC Davis
Sacramento, United States
Cypress Innovative Breast Care Center
Cypress, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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