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New 3D ultrasound aims to improve breast cancer diagnosis without radiation

NCT ID NCT07505797

Diagnosis Sponsor: iSono Health, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 2 times

Summary

This study is testing a new 3D automated ultrasound system called ATUSA to see how well it can image suspicious breast lesions. Up to 800 women with suspicious findings on standard imaging will get an ATUSA scan before their biopsy. The goal is to collect images and compare them with biopsy results to improve breast cancer detection.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ATUSA 3D Automated Breast Ultrasound System (device)
What this could lead to
If successful, this could lead to a more accurate, radiation-free, and operator-independent breast imaging tool for detecting cancer.
What could go wrong
This is an observational registry, not a treatment trial. It collects data to validate the device's image quality and may not directly change patient care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 800 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adult female participants aged 18 to 94 years with previously identified suspicious breast findings (BI-RADS® 4 or 5) detected through standard-of-care diagnostic imaging and referred for breast biopsy. Participants are enrolled at U.S. clinical sites and undergo multimodality breast imaging, including investigational ATUSA 3D automated breast ultrasound and standard-of-care imaging modalities.

Ages

18 to 94 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

breast cancer breast disorder breast fibroadenoma breast fibrocystic disease breast neoplasm cystic fibrosis female breast carcinoma invasive breast carcinoma Mastodynia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Benign breast condition Breast cancer Breast cancer detection Breast cancer female Breast cancer invasive Breast disease Breast fibroadenoma Breast neoplasms Breast pain

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cypress Innovative Breast Care Center

    RECRUITING

    Cypress, Texas, 77433, United States

  • UC Davis

    RECRUITING

    Sacramento, California, 95817, United States

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