NCT07505797Recruiting
ATUSA Ultrasound Diagnostic Imaging for Breast Lesions Evaluation (AUDIBLE) - iSono Health
ATUSA Ultrasound Diagnostic Imaging for Breast Lesions Evaluation (AUDIBLE), a Case Collection Registry for 3D Breast Automated Ultrasound Using ATUSA System as Well as Other Breast Imaging Modalities.
Source: ClinicalTrials.gov · Last updated 17 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 800 (estimated)
- First submitted
- 6 Jan 2026
- Start date
- 16 Dec 2025
- Primary completion date
- Aug 2027
- Lead sponsor
- iSono Health, Inc.
- NCT number
- NCT07505797
What you commit to
- Study type: Observational
- Planned participants: 800
- From 16 Dec 2025 to the primary completion date, Aug 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous bilateral mastectomy.
- Negative findings on diagnostic ultrasound examination within 30 days of Screening, but prior to initiating study required procedures.
Other illness
- Current pregnancy or breastfeeding status (self-reported).Documented hypersensitivity to silicone or gadolinium-based contrast agents.
- Recent (within 12 months) breast surgery or cancer treatment.
- Any medical or psychological condition that, in the Principal Investigator's judgment, could affect study participation or data integrity.
Other
- 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.
- Physical inability to maintain a supine position for 30 minutes.
- Breast anatomy incompatible with ATUSA device specifications.
Who the study is looking for
- 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.
Age in the registry: 18 years to 94 years · Sex: Female · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cypress Innovative Breast Care Center Coordinator of this site? Confirm its status | Cypress | United States | Recruiting |
| UC Davis Coordinator of this site? Confirm its status | Sacramento | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.