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NCT Number: NCT07505797

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

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.

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Key information

Conditions

Breast Cancer Benign Breast Condition Breast Cancer Detection Breast Cancer Female Breast Cancer Invasive Breast Disease Breast Diseases Breast Fibroadenoma Breast Neoplasms Breast Pain Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Digestive System Diseases Fibroadenoma Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Mastodynia Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Fibroepithelial Neoplasms, Fibrous Tissue Neoplasms, Glandular and Epithelial Neurologic Manifestations Pain Pancreatic Diseases Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–94 year

Sex eligibility

Female

Study type

Observational

Primary location

UC Davis, Sacramento, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Type and Number of breast imaging examinations collected per participant

    Time frame: From Enrollment to +/- 180 days

    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.

Secondary outcomes

  1. Overall Operator satisfaction as assessed by questionnaire

    Time frame: Day of ATUSA Imaging/Enrollment Visit (Day 0)

    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.

  2. Participant satisfaction as assessed by questionnaire

    Time frame: Day of ATUSA Imaging/Enrollment Visit (Day 0)

    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.

  3. Number of participants with adverse events related to the ATUSA system

    Time frame: Enrollment through 7 days follow-up period

    The number of participants experiencing adverse events (AEs) or serious adverse events (SAEs) related to the ATUSA system or study procedures.

Study contacts

Contact information is provided by the study sponsor or research team.

Neda Razavi

CONTACT

[email protected]

415-857-3073

Zara Hashim Naqvi

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

iSono Health, Inc.

Industry

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study 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.

Acronym: AUDIBLE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 1, 2026
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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