ATUSA Ultrasound Diagnostic Imaging for Breast Lesions Evaluation (AUDIBLE) (NCT07505797) | Clinical Trial Compass
RecruitingNot Applicable
ATUSA Ultrasound Diagnostic Imaging for Breast Lesions Evaluation (AUDIBLE)
United States800 participantsStarted 2025-12-16
Plain-language 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.
Who can participate
Age range
18 Years – 94 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Provide written informed consent through a signed and dated consent form.
. Demonstrate commitment to complete all study requirements and maintain availability for the full study duration.
. Be female, aged 18 to 94 years (inclusive).
. Have a recent BI-RADS® 4 or 5 classification confirmed through breast imaging and medical records.
Exclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial seems to be about collecting breast imaging data rather than testing a new treatment — can you help me understand what that means for me, and whether participating would have any direct impact on how my breast condition is managed?
2Since this is listed as 'Phase NA,' it sounds like it's a diagnostic imaging study rather than a drug or therapy trial — does that mean there are fewer safety risks to consider, and what, if any, are the risks of participating?
3The study is measuring how many different breast imaging exams each participant has — does that mean I would need to undergo extra ultrasounds or other imaging beyond what I'd normally need for my care, and how would that fit into my schedule?
4Given that this trial covers a wide range of breast conditions from benign fibroadenomas to invasive breast cancer, how would my doctor determine whether my specific diagnosis makes me a meaningful candidate to discuss enrolling?
5If I'm already scheduled for standard imaging as part of my diagnosis or treatment, could my doctor explain whether participating in this study would duplicate that process, delay my care in any way, or run alongside it without interfering?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Type and Number of breast imaging examinations collected per participant