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Can AI find hidden breast markers? new study aims to find out

NCT ID NCT07427407

Diagnosis Sponsor: AURA Health Technologies Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study will test an AI-enhanced ultrasound system to see if it can detect breast biopsy markers placed during standard care. About 100 adult women scheduled for breast tumor removal will have a short ultrasound scan. The AI software will try to locate the marker, but results won't change the patient's treatment. The goal is to improve future imaging tools.

What this could mean

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

What this could lead to
If successful, this AI tool could help doctors more easily find biopsy markers during breast cancer surgery, potentially improving precision.
What could go wrong
This is an early observational study with only 100 participants. The AI may not work well in all cases, and it is not yet used for diagnosis or treatment decisions.

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 100 people

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

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Dec 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

The study population consists of adult female patients receiving routine clinical care for breast tumors at an academic medical center. Participants are recruited from patients undergoing standard-of-care breast ultrasound imaging as part of their clinical treatment pathway. The study aims to include a broad range of patients and does not restrict participation based on breast size, breast density, race, ethnicity, or other demographic characteristics, in order to capture diverse imaging presentations representative of real-world clinical practice.

Ages

21 years and older

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: * Participant can understand and sign informed consent documentation * Participant has a previous placement of one of the standard-of-care breast biopsy markers Exclusion Criteria: * Previous breast cancer surgery in the region of interest * Life expectancy \<6 months * Allergy and/or hypersensitivity to titanium and/or nickel and/or ultrasound gel * Carcinoma unknown primary * Patient does not accept ultrasound examinations * Patient with skin disease of areas to be examined (breast and/or axillary)

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

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

Breast cancer

How to take part

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

  1. The places running it

    1 site. 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. 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

  • Columbia University Irving Medical Center

    New York, New York, 10032, United States

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