ATUSA Ultrasound Diagnostic Imaging for Breast Lesions Evaluation (AUDIBLE) - iSono Health

iSono Health, Inc.800 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

800

Conditions

Breast Cancer Benign Breast Condition Breast Fibroadenoma Breast Neoplasms Breast Disease

Interventions

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 94 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: From Enrollment to +/- 180 days

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Enrollment through 7 days follow-up period