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.
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 94 Years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Ultrasound, Biopsies
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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 goal is to create a comprehensive registry that includes multi-modality breast images alongside and biopsy results."
- "In addition to imaging data, the study will collect information from the patient's medical records and biopsy outcomes."
- "This study supports the advancement of a patient-friendly, radiation-free, operator-independent ultrasound platform for real-time breast imaging."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility criteria
Inclusion Criteria: 1. Provide written informed consent through a signed and dated consent form. 2. Demonstrate commitment to complete all study requirements and maintain availability for the full study duration. 3. Be female, aged 18 to 94 years (inclusive). 4. Have a recent BI-RADS® 4 or 5 classification confirmed through breast imaging and medical records. Exclusion Criteria: 1. Active skin lesions (open wounds or unhealed sores) on either breast. 2. Implanted medical devices (pacemakers, defibrillators) or MRI incompatible materials that cannot be temporarily removed. 3. Current pregnancy or breastfeeding status (self-reported).Documented hypersensitivity to silicone or gadolinium-based contrast agents. 4. Previous bilateral mastectomy. 5. Physical inability to maintain a supine position for 30 minutes. 6. Breast anatomy incompatible with ATUSA device specifications. 7. Recent (within 12 months) breast surgery or cancer treatment. 8. Negative findings on diagnostic ultrasound examination within 30 days of Screening, but prior to initiating study required procedures. 9. Any medical or psychological condition that, in the Principal Investigator's judgment, could affect study participation or data integrity.
Study sites (2)
CA
- UC Davis · Sacramento, CA 95817Dr.Shadi Aminololama-Shakeri, MD · Principal investigatorMore trials in Sacramento
TX
- Cypress Innovative Breast Care Center · Cypress, TX 77433Dr. Chirag Parghi, MD · Principal investigatorMore trials in Cypress