EICHORCondition: Breast Cancer · Sponsor: Kenko Imalytics S.L.
Interested? Contact the study team ↓
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.
This description comes directly from the study's public registry record.
Raquel Laza Bulls · +34 697 70 84 87 · raquel.laza@kenkoimalytics.com
Eric Aguado Sarrió · +34 669 953 839 · eric@kenkoimalytics.com
There is no obligation to join — the study team can answer your questions about taking part.
Always discuss trial participation with your own doctor first.
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.
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Hospital Universitario del Vinalopó | Elche, Alicante, Spain | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07580105