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:
- 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.
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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1
UC Davis
Sacramento, California, United States, 95817