Benign Breast Condition, Breast Cancer, Breast Cancer Detection, Breast Cancer Female, Breast Cancer Invasive, Breast Disease, Breast Fibroadenoma, Breast Neoplasms, Breast Pain
Conditions
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
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 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.
Interventions
DEVICEATUSA 3D Automated Breast Ultrasound System
The ATUSA system is an FDA-cleared Class II automated breast ultrasound device used in this study for investigational data collection purposes only. The device consists of a portable automated ultrasound scanner, a wearable positioning accessory, disposable components, and associated software that acquires three-dimensional ultrasound images of the breast. In this observational registry study, ATUSA imaging is performed to collect multimodality breast imaging data and is not used to guide clinical diagnosis, treatment decisions, or patient management. All clinical assessments and care, including biopsy and diagnostic interpretation, are performed according to standard of care.
Sponsors
iSono Health, Inc.
National Cancer Institute (NCI)
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 94 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Type and Number of breast imaging examinations collected per participant | From Enrollment to +/- 180 days | 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
| Measure | Time frame | Description |
|---|---|---|
| Overall Operator satisfaction as assessed by questionnaire | Day of ATUSA Imaging/Enrollment Visit (Day 0) | 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. |
| Participant satisfaction as assessed by questionnaire | Day of ATUSA Imaging/Enrollment Visit (Day 0) | 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 patient satisfaction with medical device. The form uses 5-point Likert-scale responses ranging from 1 (Strongly Disagree) to 5 (Strongly Agree), with higher scores indicating more favorable outcome. |
| Number of participants with adverse events related to the ATUSA system | Enrollment through 7 days follow-up period | The number of participants experiencing adverse events (AEs) or serious adverse events (SAEs) related to the ATUSA system or study procedures. |
Countries
United States
Contacts
CONTACTNeda Razavi
CONTACTZara Hashim Naqvi
Outcome results
None listed