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

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.

NCT Number	NCT07580105
Lead Sponsor	Kenko Imalytics S.L. Collaborators: MDx CRO (MED IVD HEALTHTECH S.L.)
Conditions	Breast Cancer
Enrollment	200 participants
Start Date	2026-07-22
Primary Completion	2027-05 (estimated)
Study Completion	2027-05 (estimated)
Updated on ClinicalTrials.gov	2026-08-05