ATUSA Ultrasound Diagnostic Imaging for Breast Lesions Evaluation (AUDIBLE)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ATUSA 3D Automated Breast Ultrasound System.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Benign Breast Condition, Breast Fibroadenoma, Breast Neoplasms. Basic parameters: 18 years — 94 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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.
Overview
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 clinic
Primary outcome measures
- Type and Number of breast imaging examinations collected per participant [Time frame: From Enrollment to +/- 180 days]
Secondary outcome measures (3)
- Overall Operator satisfaction as assessed by questionnaire [Time frame: Day of ATUSA Imaging/Enrollment]
- Participant satisfaction as assessed by questionnaire [Time frame: Day of ATUSA Imaging/Enrollment]
- Number of participants with adverse events related to the ATUSA system [Time frame: Enrollment through 7 days follow-up period]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- UC Davis — Sacramento
Identifiers
NCT: NCT07505797 · CP0004 · 1R44CA291498