NCT07505797 · iSono Health, Inc.
ATUSA Ultrasound Diagnostic Imaging for Breast Lesions Evaluation (AUDIBLE)
(AUDIBLE)
What this study 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.
View original scientific description
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.
Interventions
DEVICE
ATUSA 3D Automated Breast Ultrasound System
The ATUSA system is an FDA-cleared Class II automated breast ultrasound device used in this study for investigational data collection purposes only. The device consists of a portable automated ultrasound scanner, a wearable positioning accessory, disposable components, and associated software that acquires three-dimensional ultrasound images of the breast. In this observational registry study, ATUSA imaging is performed to collect multimodality breast imaging data and is not used to guide clinical diagnosis, treatment decisions, or patient management. All clinical assessments and care, including biopsy and diagnostic interpretation, are performed according to standard of care.
Primary outcome measures
Type and Number of breast imaging examinations collected per participant
Time frame: From Enrollment to +/- 180 days
The breast imaging exams (type and number) performed per patient (ATUSA, DBT, HHUS, MRI, and, if applicable, other exams such as FFDM) and number of biopsy-confirmed cancer cases.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
- Current pregnancy or breastfeeding status (self-reported).Documented hypersensitivity to silicone or gadolinium-based contrast agents.
- Previous bilateral mastectomy.
- Physical inability to maintain a supine position for 30 minutes.
- Breast anatomy incompatible with ATUSA device specifications.
- Recent (within 12 months) breast surgery or cancer treatment.
- Negative findings on diagnostic ultrasound examination within 30 days of Screening, but prior to initiating study required procedures.
- Any medical or psychological condition that, in the Principal Investigator's judgment, could affect study participation or data integrity.
Where
- Sacramento, California
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 1, 2026 · Source of record for eligibility and locations