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Observational Study for AI-Based Detection of Breast Biopsy Markers

This observational study is collecting ultrasound images to help develop and improve a special artificial intelligence (AI) software. This software is designed to find and locate breast biopsy markers (small clips placed in the breast during a biopsy) using an FDA-cleared breast ultrasound system. The goal is to see if this AI software can successfully identify these markers during a routine ultrasound. You may be able to join if you are an adult woman, aged 21 or older, who has had a breast biopsy marker placed previously. This study is currently unclear on its recruitment status and plans to enroll about 100 participants.

Study design
This is an observational study, meaning it collects information without changing your standard medical care. It aims to enroll about 100 participants.
What's involved
You will undergo a limited breast ultrasound imaging during a scheduled clinical visit, which takes approximately 5-10 minutes. This is part of your routine care.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured during a single ultrasound imaging session, lasting approximately 5-10 minutes. No further follow-up is specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07427407

Prospective Ultrasound Data Collection Study for AI-Based Detection of Breast Biopsy Markers

Not Yet Recruiting
Not specifiedAges 21+Observational
AURA Health Technologies
~100 participants
Updated 2026-02-24 on ClinicalTrials.gov
What's tested:Breast Ultrasound Imaging With Investigational AI Software

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Successful Identification of Breast Biopsy Marker
Measured over During the ultrasound imaging examination (single imaging session; approximately 5-10 minutes)

Conditions

Breast Cancer

Explore related trials

Breast Carcinoma

Where it's being run

1 sites across 1 states
New York1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Participant can understand and sign informed consent documentation
Participant has a previous placement of one of the standard-of-care breast biopsy markers

Exclusion

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)

What this trial measures

  • Successful Identification of Breast Biopsy MarkerDuring the ultrasound imaging examination (single imaging session; approximately 5-10 minutes)

    Whether the investigational software identifies the location of a previously placed standard-of-care breast biopsy marker during ultrasound imaging.