Recruiting

ATUSA

Sponsor:

iSono Health, Inc.

Code:

NCT07505797

Conditions

Breast Cancer

Benign Breast Condition

Breast Fibroadenoma

Breast Neoplasms

Breast Disease

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

ATUSA 3D Automated Breast Ultrasound System

Study Details

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

Study ID

NCT07505797

Start date

Dec 16, 2025

Status verified date

Mar, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Nov 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

800 participants

Anticipated

Interventions and Outcome Measures

Interventions

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 clinical diagnosis, treatment decisions, or patient management. All clinical assessments and care, including biopsy and diagnostic interpretation, are performed according to standard of care.

Primary outcome measure

  • Type and Number of breast imaging examinations collected per participant [ Time Frame: From Enrollment to +/- 180 days ]

Central Contacts and Locations

Central contacts

Neda Rezavi

6505076601neda@isonohealth.com

Chirag Parghi

contact@isonohealth.com

Locations

UC Davis

Recruiting

Sacramento, California, United States, 95817

Contacts

Allison Proffitt

916-734-3101agproffitt@health.ucdavis.edu

Abel Garibay-Olivarez

adgaribay@health.ucdavis.edu

More Information

Sponsor

iSono Health, Inc.

Last update posted

Apr 1, 2026

Last verified

Mar, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by iSono Health, Inc. on 2026-04-01.