[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637256":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":30,"responsibleParty":52,"collaborators":54,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":10,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":10,"enrollmentInfo":67,"targetDuration":10,"studyType":70,"phases":10,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":33,"whyStopped":10,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Kenko Imalytics S.L.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Participants",null,"Adult women with suspected breast cancer or under surveillance for the disease",[13],"Device: Kenko Breast AI+",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","Kenko Breast AI+","Kenko Breast AI+ is a medical software that processes breast magnetic resonance imaging (MRI) sequences to generate parametric maps of imaging biomarkers related to vascularization and cellularity. These maps assist radiologists in detecting, characterizing, and grading breast lesions, supporting diagnosis of malignancy and assessment of tumor aggressiveness. The software functions as a non-invasive imaging biomarker tool intended to complement, not replace, molecular and histopathological diagnostics.\n\nKenko Breast AI+ is a Class IIb medical device.\n\nThe assessment of MRI breast cases with Kenko Breast AI+ will be compared with the assessment of MRI breast cases without Kenko Breast AI+ as per routine clinical practice.\n\nThe ground truth diagnosis will be established by routine clinical practice and may include a combination of clinical assessment, imaging results, tissue biopsy, and pathology reports.",[9],[21,26],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Raquel Laza Bulls","CONTACT","+34 697 70 84 87","raquel.laza@kenkoimalytics.com",{"name":27,"role":23,"phone":28,"phoneExt":10,"email":29},"Eric Aguado Sarrió","+34 669 953 839","eric@kenkoimalytics.com",[31],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Hospital Universitario del Vinalopó","RECRUITING","Elche","Alicante","03293","Spain","ES",{"type":40,"coordinates":41},"Point",[42,43],-0.70107,38.26218,{"lat":43,"lon":42},[46,49],{"name":32,"role":23,"phone":47,"phoneExt":10,"email":48},"+34 966 67 98 00","info@vinaloposalud.com",{"name":50,"role":51,"phone":10,"phoneExt":10,"email":10},"Julia Camps Herrero, MD","PRINCIPAL_INVESTIGATOR",{"type":53,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[55],{"name":56,"class":57},"MDx CRO (MED IVD HEALTHTECH S.L.)","UNKNOWN","100637256","clinical-study-to-assess-the-safety-and-performance-of-kenko-breast-ai-medical-device-as-an-aid-to-breast-cancer-diagnosis-in-adult-women-100637256",false,"NCT07580105","Clinical Study to Assess the Safety and Performance of Kenko Breast AI+ Medical Device as an Aid to Breast Cancer Diagnosis in Adult Women","Clinical Pre-Market, Observational, Prospective, Blinded, Controlled, Single-Center Study to Assess the Safety and Performance of Kenko Breast AI+ Medical Device as an Aid to Breast Cancer Diagnosis in Adult Women","Inclusion Criteria:\n\n1. 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:\n\n   1. Staging,\n   2. Assessment of response to neoadjuvant therapy,\n   3. High suspicion of breast cancer, or\n   4. Follow-up.\n2. 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.\n3. Women age 18 and older.\n4. Adult women able to understand the informed consent and participant information sheet and provide voluntary consent for the study.\n\nExclusion Criteria:\n\n1. Pregnant women.\n2. Individuals with incomplete or invalid perfusion, diffusion or T2 MRI sequences.\n3. Individuals for whom MRI is contraindicated or not feasible.","FEMALE","18 Years",{"count":68,"type":69},200,"ESTIMATED","OBSERVATIONAL","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.\n\nThe main questions it aims to answer is:\n\n* Does Kenko Breast AI+ help healthcare professionals find possible signs of breast cancer more accurately and efficiently when they read MRI scans?\n* Does using the software cause any safety problems or software-related issues during the study?\n\nResearchers will compare MRI readings done with the software to readings done without it.\n\nParticipants will attend their regularly scheduled breast MRI appointment. All diagnoses are based on standard medical care, not on the study software.",[73],"Breast Cancer",[75,73,76,77,78],"Breast Cancer Detection","Image Analysis","Breast MRI","Medical Imaging Software","2026-08-03",{"date":81,"type":82},"2026-08-05","ACTUAL",{"date":84,"type":82},"2026-07-22",{"date":86,"type":69},"2027-05",{"name":5,"class":6},1]