ATUSA Ultrasound Diagnostic Imaging for Breast Lesions Evaluation (AUDIBLE) (AUDIBLE)

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Breast Neoplasms; Breast Cancer Female; Breast Fibroadenoma; Breast Cancer Invasive; Breast Pain; Breast Disease; Benign Breast Condition
• Intervention / Treatment: Device: ATUSA 3D Automated Breast Ultrasound System

• Study Type: Observational
• Enrollment (Estimated): 800

Contacts and Locations

• Study Contact: Name: Neda Rezavi; Phone Number: 6505076601; Email: neda@isonohealth.com
• Study Contact Backup: Name: Chirag Parghi; Email: contact@isonohealth.com

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • Recruiting
      • UC Davis
      • Contact: Allison Proffitt; Phone Number: 916-734-3101; Email: agproffitt@health.ucdavis.edu
      • Contact: Abel Garibay-Olivarez; Email: adgaribay@health.ucdavis.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From Enrollment to +/- 180 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day of ATUSA Imaging/Enrollment
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.	Day of ATUSA Imaging/Enrollment
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.	Enrollment through 7 days follow-up period

Collaborators and Investigators

• Sponsor: iSono Health, Inc.
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2025
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 6, 2026
• First Submitted That Met QC Criteria: March 26, 2026
• First Posted (Actual): April 1, 2026

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: breast cancer; ultrasound; medical device; AI; ABUS; registry; image quality; benign breast disease; dense breasts; multimodality imaging; invasive breast carcinoma; breast lesions; ATUSA; Automated Breast Utrasound; Ultrasound breast imaging; AI Model Training; iSono Health
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neoplasms by Site; Neoplasms; Genetic Diseases, Inborn; Respiratory Tract Diseases; Neoplasms by Histologic Type; Digestive System Diseases; Lung Diseases; Infant, Newborn, Diseases; Pancreatic Diseases; Neoplasms, Glandular and Epithelial; Skin Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms, Connective Tissue; Neoplasms, Fibrous Tissue; Neoplasms, Fibroepithelial; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Signs and Symptoms; Breast Neoplasms; Cystic Fibrosis; Breast Diseases; Mastodynia; Fibroadenoma
• Other Study ID Numbers: CP0004; 1R44CA291498 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No