Status:

RECRUITING

ATUSA Ultrasound Diagnostic Imaging for Breast Lesions Evaluation (AUDIBLE)

Lead Sponsor:

iSono Health, Inc.

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Breast Cancer

Benign Breast Condition

Eligibility:

FEMALE

18-94 years

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 femal...

Eligibility Criteria

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.

Key Trial Info

Start Date :

December 16 2025

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 31 2026

Estimated Enrollment :

800 Patients enrolled

Trial Details

Trial ID

NCT07505797

Start Date

December 16 2025

End Date

December 31 2026

Last Update

April 1 2026

Active Locations (1)

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Page 1 of 1 (1 locations)

1

UC Davis

Sacramento, California, United States, 95817