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ATUSA Ultrasound Diagnostic Imaging for Breast Lesions Evaluation (AUDIBLE)

NCT07505797 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 800

Last updated 2026-04-01

No results posted yet for this study

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

Interventions

DEVICE

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • iSono Health, Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
94 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-16
Primary Completion
2026-11-15
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07505797 on ClinicalTrials.gov