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.

Plain English Summary

ATUSA Ultrasound Diagnostic Imaging for Breast Lesions Evaluation (AUDIBLE) is a Not Applicable clinical trial sponsored by iSono Health, Inc. studying Breast Cancer, Benign Breast Condition, Breast Fibroadenoma, Breast Neoplasms, Breast Disease, Breast Cancer Female, Breast Pain, Breast Cancer Invasive. This study tests a new 3D automated ultrasound system (ATUSA) for evaluating breast lesions. It's for women aged 18-94 with suspicious breast findings (BI-RADS 4 or 5) who are already scheduled for a biopsy. Participation involves undergoing ATUSA ultrasound imaging, providing medical records, and allowing biopsy results to be collected. Alternatives include standard hand-held ultrasound, mammography, and MRI, which are already part of the diagnostic process. The trial aims to enroll 800 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Women aged 18 to 94 who have suspicious breast findings (BI-RADS 4 or 5) confirmed by imaging and are referred for biopsy can join. You cannot join if you have active skin lesions on your breasts, certain implanted medical devices, are pregnant or breastfeeding, have had both breasts removed, or have had recent breast surgery or cancer treatment. You must be able to lie flat for about 30 minutes and have breast anatomy compatible with the ATUSA device. This trial is studying Breast Cancer, Benign Breast Condition, Breast Fibroadenoma, Breast Neoplasms, Breast Disease, Breast Cancer Female, Breast Pain, Breast Cancer Invasive, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures the amount and types of breast imaging collected, which helps ensure the study gathers enough data to assess the new ultrasound system's performance. The specific primary outcome measures are: Type and Number of breast imaging examinations collected per participant (From Enrollment to +/- 180 days). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial matters because it aims to improve breast cancer detection and monitoring with a radiation-free, patient-friendly ultrasound technology, potentially filling a gap in current imaging options This research targets Breast Cancer, Benign Breast Condition, Breast Fibroadenoma, Breast Neoplasms, Breast Disease, Breast Cancer Female, Breast Pain, Breast Cancer Invasive, where improved treatment options are needed.

Investor Insight

This observational registry study by iSono Health, Inc. aims to collect data to support the validation of their ATUSA system, a potentially competitive, radiation-free alternative in the breast imagin The large enrollment target of 800 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor if the ATUSA system is appropriate for your specific breast findings and how it differs from standard ultrasound. Participation involves undergoing the ATUSA ultrasound, which is automated and operator-independent, and providing consent for your medical records and biopsy results to be used. You will be asked to complete questionnaires about your satisfaction with the imaging process. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: OBSERVATIONAL
• Enrollment: 800 participants

Interventions

• DEVICE: ATUSA 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 clinic

Primary Outcomes

• Type and Number of breast imaging examinations collected per participant (From Enrollment to +/- 180 days)

Secondary Outcomes

• Overall Operator satisfaction as assessed by questionnaire (Day of ATUSA Imaging/Enrollment)
• Participant satisfaction as assessed by questionnaire (Day of ATUSA Imaging/Enrollment)
• Number of participants with adverse events related to the ATUSA system (Enrollment through 7 days follow-up period)

Full Eligibility Criteria

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.

Trial Locations

• UC Davis, Sacramento, California, United States

Frequently Asked Questions

Related Conditions

• Breast Cancer
• Benign Breast Condition
• Breast Fibroadenoma
• Breast Neoplasms
• Breast Disease
• Breast Cancer Female
• Breast Pain
• Breast Cancer Invasive
• Breast Imaging
• Diagnostic Ultrasound

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