Breast CancerAUDIBLENCT07505797
ATUSA Ultrasound Diagnostic Imaging for Breast Lesions Evaluation (AUDIBLE) - iSono Health
An observational study of Breast Cancer and Benign Breast Condition, run by iSono Health, Inc. at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 94 years, women only
- Conditions the study is for
- Breast Cancer, Benign Breast Condition, Breast Fibroadenoma
- What is being tested?
- ATUSA 3D Automated Breast Ultrasound System
- Type of treatment
- Medical device
- How many people
- 800 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Dec 2025to Aug 2027
- How long will I take part?
- 7 Days
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 94 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult female participants aged 18 to 94 years with previously identified suspicious breast findings (BI-RADS® 4 or 5) detected through standard-of-care diagnostic imaging and referred for breast biopsy. Participants are enrolled at U.S. clinical sites and undergo multimodality breast imaging, including investigational ATUSA 3D automated breast ultrasound and standard-of-care imaging modalities.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Zara Hashim Naqvi contact
United States2 sites, 2 recruiting
- Recruiting
Cypress Innovative Breast Care Center
Cypress, Texas, 77433
Dr. Chirag Parghi, MD
- Recruiting
UC Davis
Sacramento, California, 95817
Dr.Shadi Aminololama-Shakeri, MD
About this study
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.
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.
- Conditions
- Breast Cancer, Benign Breast Condition, Breast Fibroadenoma, Breast Neoplasms, Breast Disease, Breast Cancer Female
- Being tested
- ATUSA 3D Automated Breast Ultrasound System
- Keywords
- breast cancer, breast lesions, dense breasts, invasive breast carcinoma, benign breast disease, ATUSA, Automated Breast Utrasound, ABUS, Ultrasound breast imaging, multimodality imaging, ultrasound, registry, image quality, AI, AI Model Training, medical device, iSono Health, US Study, USA, Machine Learning
- Medical subject headings
- Breast Neoplasms, Fibroadenoma, Breast Diseases, Mastodynia, Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATUSA 3D Automated Breast Ultrasound SystemDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Type and Number of breast imaging examinations collected per participant
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.
Measured: From Enrollment to +/- 180 days
Secondary outcomes (3)
Overall Operator satisfaction as assessed by questionnaire
Key factors influencing the successful implementation of ATUSA in a clinical setting and the barriers that impede its integration. The questionnaire consists of multiple items assessing operator satisfaction with the medical device. The form uses 5-point Likert-scale responses ranging from 1 (Strongly Agree) to 5 (Strongly Disagree), with higher scores indicating more unfavorable outcome.
Measured: Day of ATUSA Imaging/Enrollment Visit (Day 0)
Participant satisfaction as assessed by questionnaire
Key factors influencing the successful implementation of ATUSA in a clinical setting and the barriers that impede its integration. The questionnaire consists of multiple items assessing patient satisfaction with medical device. The form uses 5-point Likert-scale responses ranging from 1 (Strongly Disagree) to 5 (Strongly Agree), with higher scores indicating more favorable outcome.
Measured: Day of ATUSA Imaging/Enrollment Visit (Day 0)
Number of participants with adverse events related to the ATUSA system
The number of participants experiencing adverse events (AEs) or serious adverse events (SAEs) related to the ATUSA system or study procedures.
Measured: Enrollment through 7 days follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start16 Dec 2025
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- iSono Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07505797
- Sponsor's protocol ID
- CP0004
- Other IDs
- 1R44CA291498
- Acronym
- AUDIBLE
- Status last verified
- Sep 2026
- First submitted
- 6 Jan 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No