Clinical trial · Observational

ATUSA Ultrasound Diagnostic Imaging for Breast Lesions Evaluation (AUDIBLE) - iSono Health

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.

NCT07505797CI-TRIAL-00107082AUDIBLErecruitingClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (9)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Benign Breast Condition	—	UNRESOLVED	—
Breast Cancer	Malignant Breast Neoplasm	CURATED_EXACT	0.92
Breast Cancer Detection	—	UNRESOLVED	—
Breast Cancer Female	—	UNRESOLVED	—
Breast Cancer Invasive	—	UNRESOLVED	—
Breast Disease	—	UNRESOLVED	—
Breast Fibroadenoma	Breast Fibroadenoma	ONTOLOGY_EXACT	0.98
Breast Neoplasms	Breast Neoplasm	ONTOLOGY_EXACT	0.98
Breast Pain	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
ATUSA 3D Automated Breast Ultrasound System	Device	—	UNRESOLVED

Design

Arms and outcomes

Arms (0)

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Primary outcomes (1)

measure
Type and Number of breast imaging examinations collected per participant
timeFrame
From Enrollment to +/- 180 days
description
The breast imaging exams (type and number) performed per patient (ATUSA, DBT, HHUS, MRI, and, if applicable, other exams such as FFDM) and number of biopsy-confirmed cancer cases.

Secondary outcomes (3)

measure
Overall Operator satisfaction as assessed by questionnaire
timeFrame
Day of ATUSA Imaging/Enrollment Visit (Day 0)
description
Key factors influencing the successful implementation of ATUSA in a clinical setting and the barriers that impede its integration. The questionnaire consists of multiple items assessing operator satisfaction with the medical device. The form uses 5-point Likert-scale responses ranging from 1 (Strongly Agree) to 5 (Strongly Disagree), with higher scores indicating more unfavorable outcome.
measure
Participant satisfaction as assessed by questionnaire

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 18 Years
Maximum age: 94 Years

Show eligibility criteria text

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.

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Dec 16, 2025
Primary completion: Aug 1, 2027
Completion: Aug 1, 2027
First posted: Apr 1, 2026
Last update posted: Sep 17, 2026
Enrollment: 800 (estimated)
Lead sponsor: iSono Health, Inc. INDUSTRY
Collaborators: National Cancer Institute (NCI)
Keywords: breast cancer, 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, US Study, USA, Machine Learning, Mammography, Digital Mammography, Medical Imaging, Cancer Diagnosis, Early Cancer Detection, Computer-aided detection, Breast screening, Breast MRI, Breast Tumor, Breast mass evaluation, Diagnostic Imaging Device

Data updated 12 days agoSource updated Sep 17, 2026source: clinicaltrials

Locations

Locations by country (2)

Country	Sites	Recruiting