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Clinical Study to Assess the Safety and Performance of Kenko Breast AI+ Medical Device as an Aid to Breast Cancer Diagnosis in Adult Women

Recruitingn/aAges 18 Years - anyFemaleKenko Imalytics S.L.
NCT07580105 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this observational study is to learn whether a new medical software tool called Kenko Breast AI+ can help healthcare professionals read breast magnetic resonance imaging (MRI) scans better to help diagnose breast cancer. The study includes adult women who may have breast cancer or who are being followed for the disease. The main questions it aims to answer is: * Does Kenko Breast AI+ help healthcare professionals find possible signs of breast cancer more accurately and efficiently when they read MRI scans? * Does using the software cause any safety problems or software-related issues during the study? Researchers will compare MRI readings done with the software to readings done without it. Participants will attend their regularly scheduled breast MRI appointment. All diagnoses are based on standard medical care, not on the study software.

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📋 Eligibility rules (as published)
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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What it tests

  • Kenko Breast AI+
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Where

1 site
Hospital Universitario del Vinalopó
Elche, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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