AI eye on cancer: new software aims to sharpen breast MRI readings

NCT ID NCT07580105

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Recruiting now This study
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Registered, but not yet taking participants.
By invitation only
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Paused for now. It may or may not start again.
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Running, but no longer taking on new participants.
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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 Results may not be published yet.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)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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Not a trial. The treatment could once be requested outside a study, but no longer can.
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First seen Jun 27, 2026 · Last updated Aug 06, 2026 · Updated 2 times

Summary

This study tests whether a new software tool, Kenko Breast AI+, can help doctors read breast MRI scans more accurately to diagnose breast cancer. About 200 adult women who may have breast cancer or are being monitored for it will take part. Researchers will compare MRI readings done with and without the AI software to see if it improves detection and efficiency. The study is observational, meaning participants receive standard care and the software is not used for actual diagnosis.

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 200 people

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

Started

Jul 2026

Expected to finish

May 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

Prospective data will be collected from adult women with suspected or diagnosed breast cancer undergoing breast MRI as part of routine clinical care at Hospital Universitario del Vinalopó.

Ages

18 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 with suspected breast cancer or under surveillance for the disease who have undergone MRI including perfusion (DCE-MRI), diffusion (DTI-MRI) and T2 sequences, performed for the purposes of: 1. Staging, 2. Assessment of response to neoadjuvant therapy, 3. High suspicion of breast cancer, or 4. Follow-up. 2. For participants who have undergone MRI for follow-up purposes, prior breast MRI data collected at the most 12 months before the screening visit must be available. 3. Women age 18 and older. 4. Adult women able to understand the informed consent and participant information sheet and provide voluntary consent for the study. Exclusion Criteria: 1. Pregnant women. 2. Individuals with incomplete or invalid perfusion, diffusion or T2 MRI sequences. 3. Individuals for whom MRI is contraindicated or not feasible.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

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    Open the record ↗

  4. A doctor treating you

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Contacts and locations

Locations

  • Hospital Universitario del Vinalopó

    RECRUITING

    Elche, Alicante, 03293, Spain

    Contact Email: •••••@•••••

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