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AI boosts breast cancer detection in ultrasound study

NCT ID NCT07287111

Diagnosis Sponsor: BeamWorks Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested whether an AI program called CadAI-B Dx helps doctors better detect breast cancer on ultrasound images. Researchers compared how 16 doctors performed with and without the AI's help, using 797 cases (350 with cancer, 447 benign). The goal was to see if the AI improves accuracy and reduces missed cancers.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

797 people

The number who actually took part.

Started

Aug 2025

Finished

Nov 2025

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.

Ages

22 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: 1. Women aged 22 years or older at the time of the breast ultrasound examination. 2. Standard B-mode breast ultrasound images available for analysis. 3. Lesions must have a confirmed diagnosis based on one of the following reference standards: 3-1. Malignant Cases: Diagnosis of breast cancer confirmed through biopsy or surgery. 3-2. Benign Cases: Confirmed as benign through biopsy or surgical excision, or confirmed as having no evidence of malignancy for at least 2 years of follow-up. Exclusion Criteria: 1. mages containing modes other than standard B-mode ultrasound, such as Doppler, elastography, or other annotations/overlays. 2. Patients who have breast implant(s). 3. Patients suffering from significant breast trauma or mastitis at the time of the breast ultrasound examination. 4. Images of post-surgical resection sites. 5. Images where multiple lesions are present within a single 2D ultrasound image

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Conditions

The condition(s) this trial relates to.

breast benign neoplasm breast cancer breast neoplasm

As listed by the trial registrant

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

Breast cancer Breast neoplasms

Contacts and locations

Locations

  • Yonsei University Severance Hospital

    Seoul, 03722, South Korea

More trials for these conditions

Other studies related to the condition(s) this trial covers.