Last reviewed · How we verify
NCT07505797: AUDIBLE
ATUSA Ultrasound Diagnostic Imaging for Breast Lesions Evaluation (AUDIBLE)
trial testing ATUSA 3D Automated Breast Ultrasound System in Breast Cancer in 800 participants. Currently enrolling.
15 November 2026
Quick facts
| Lead sponsor | iSono Health, Inc. |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 800 |
| Start date | 16 December 2025 |
| Primary completion | 15 November 2026 |
| Estimated completion | 31 December 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- ATUSA 3D Automated Breast Ultrasound System
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
- Benign Breast Condition — all drugs for Benign Breast Condition →
- Breast Fibroadenoma — all drugs for Breast Fibroadenoma →
- Breast Neoplasms — all drugs for Breast Neoplasms →
Sponsor
iSono Health, Inc.
Who can join
Adults 18 to 94, female only, with Breast Cancer or Benign Breast Condition. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07505797
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07505797 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by iSono Health, Inc.
- Last refreshed: 1 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07505797.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing