ATUSA Ultrasound Diagnostic Imaging for Breast Lesions Evaluation (AUDIBLE)

a study on Breast Cancer Benign Breast Condition Breast Fibroadenoma Breast Pain Cystic Fibrosis Fibrosis

Summary

Eligibility
for females ages 18-94 (full criteria)
Location
at UC Davis
Dates
study started
study ends around

Description

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.

Official 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.

Keywords

Breast Cancer, Benign Breast Condition, Breast Fibroadenoma, Breast Neoplasms, Breast Disease, Breast Cancer Female, Breast Pain, Breast Cancer Invasive, breast lesions, dense breasts, invasive breast carcinoma, benign breast disease, ATUSA, Automated Breast Utrasound, ABUS, Ultrasound breast imaging, multimodality imaging, ultrasound, registry, image quality, AI, AI Model Training, medical device, iSono Health, Fibroadenoma, Breast Diseases, Mastodynia, Cystic Fibrosis, ATUSA 3D Automated Breast Ultrasound System

Eligibility

You can join if…

Open to females ages 18-94

  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.

You CAN'T join if...

  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.

Location

  • UC Davis accepting new patients
    Sacramento California 95817 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
iSono Health, Inc.
ID
NCT07505797
Study Type
Observational [Patient Registry]
Participants
Expecting 800 study participants
Last Updated
Contact us about this trial