Actively Recruiting
ATUSA Ultrasound Diagnostic Imaging for Breast Lesions Evaluation (AUDIBLE)
Led by iSono Health, Inc. · Updated on 2026-04-01
800
Participants Needed
1
Research Sites
54 weeks
Total Duration
On this page
Sponsors
I
iSono Health, Inc.
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
ATUSA Ultrasound Diagnostic Imaging for Breast Lesions Evaluation (AUDIBLE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent through a signed and dated consent form.
- Commit to completing all study requirements and remain available for the full study duration.
- Female, aged 18 to 94 years (inclusive).
- Have a recent BI-RADS 4 or 5 classification confirmed through breast imaging and medical records.
You will not qualify if you...
- Active skin lesions (open wounds or unhealed sores) on either breast.
- Implanted medical devices (pacemakers, defibrillators) or MRI incompatible materials that cannot be temporarily removed.
- Currently pregnant or breastfeeding (self-reported).
- Documented hypersensitivity to silicone or gadolinium-based contrast agents.
- Previous bilateral mastectomy.
- Unable to maintain a supine position for 30 minutes.
- Breast anatomy incompatible with ATUSA device specifications.
- Breast surgery or cancer treatment within the last 12 months.
- Negative findings on diagnostic ultrasound within 30 days before starting study procedures.
- Any medical or psychological condition that could affect participation or data quality, as judged by the Principal Investigator.
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Trial Site Locations
Total: 1 location
1
UC Davis
Sacramento, California, United States, 95817
Actively Recruiting
Research Team
N
Neda Rezavi
CONTACT
C
Chirag Parghi
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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