AI eye on cancer: new software aims to sharpen breast MRI readings
NCT ID NCT07580105
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.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Locations
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Hospital Universitario del Vinalopó
RECRUITINGElche, Alicante, 03293, Spain
Contact Email: •••••@•••••
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