ATUSA Ultrasound Diagnostic Imaging for Breast Lesions Evaluation (AUDIBLE)

NCT07505797 | Recruiting FDA Device

• 2 other identifiers: CP00041R44CA291498
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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 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; Breast Pain; Breast Cancer Invasive

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Overall Operator satisfaction as assessed by questionnaire

  Day of ATUSA Imaging/Enrollment

• Participant satisfaction as assessed by questionnaire

  Day of ATUSA Imaging/Enrollment

• Number of participants with adverse events related to the ATUSA system

  Enrollment through 7 days follow-up period

Interventions

ATUSA 3D Automated Breast Ultrasound System DEVICE

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.

Eligibility Criteria

• Age: 18 Years - 94 Years
• Gender Eligibility Details: Females
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• iSono Health, Inc.: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

UC Davis

Sacramento, California, 95817, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Fibroadenoma; Breast Diseases; Mastodynia; Cystic Fibrosis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasms, Fibroepithelial; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Central Study Contacts

Neda Rezavi

CONTACT

6505076601; neda@isonohealth.com

Chirag Parghi

CONTACT

contact@isonohealth.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: April 1, 2026
• Study Start: December 16, 2025
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)