ATUSA Ultrasound Diagnostic Imaging for Breast Lesions Evaluation (AUDIBLE) - iSono Health
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Kobieta w wieku 18-94 lata
- •Podpisana zgoda na udział w badaniu
- •Ostatnie wyniki badań piersi wykazały podejrzane zmiany (klasyfikacja BI-RADS 4 lub 5)
- •Gotowość do uczestnictwa w całym badaniu przez wymagany czas
✗ Disqualifies
- •Otwarte rany lub niezagojone skaleczenia na piersiach
- •Wszzczepione urządzenia medyczne (rozrusznik serca, defibrylatор), które nie można czasowo usunąć
- •Obecna ciąża lub karmienie piersią
- •Usunięcie obu piersi w przeszłości
- •Niemożliwość leżenia na plecach przez 30 minut
- •Badanie ultrasonograficzne z ostatniego miesiąca wykazało brak zmian
- •Operacja piersi lub leczenie raka w ostatnich 12 miesiącach
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 94 Years
- Last updated (source)
- September 17, 2026
- Sex
- Female only
Therapies / drugs in trial
Locations (2)
UC Davis
Sacramento, United States
Cypress Innovative Breast Care Center
Cypress, United States
Trial contact
Neda Razavi
Zara Hashim Naqvi
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/18/2026.
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