[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100518580":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":43,"responsibleParty":59,"collaborators":61,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":79,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":25,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":46,"whyStopped":25,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Norwegian Institute of Public Health","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention arm","EXPERIMENTAL","AI assisted mammography screening interpretation",[13],"Other: AI assisted mammography screening interpretation",{"label":15,"type":16,"description":17,"interventionNames":18},"Control arm","ACTIVE_COMPARATOR","Standard mammography screening interpretation (standard procedure)",[19],"Other: Standard mammography screening interpretation",[21,26],{"type":22,"name":11,"description":23,"armGroupLabels":24,"otherNames":25},"OTHER","Screening examinations will be analyzed by the AI system (Transpara, ScreenPoint Medical, Nijmegen, The Netherlands) that assigns each examination a cancer risk score 1-10. Examinations with a score 1-7 will be single read and examinations with score 8-10 will be double read. Examinations selected by one or two readers will be discussed in a consensus meeting. Examinations with an AI score of \\>9.8 will be selected for the consensus meeting by default. AI risk scores and image markings are provided to the readers only in the consensus meetings. The readers will decide whether to recall the woman for further assessment in consensus (standard procedure).",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Standard mammography screening interpretation","Screening examinations will be assessed according to standard of care: independently double read, examinations selected by one or two readers will be discussed in a consensus meeting, and the radiologists will decide whether to recall the woman for further assessment. Screening examinations will be analyzed by the AI system retrospectively but the results will not be made available to the radiologist, only used for comparison to the intervention group in results analyses.",[15],[31],{"name":32,"affiliation":5,"role":33},"Solveig Hofvind, PhD","PRINCIPAL_INVESTIGATOR",[35,40],{"name":32,"role":36,"phone":37,"phoneExt":38,"email":39},"CONTACT","22928828","+47","sshh@kreftregisteret.no",{"name":41,"role":36,"phone":25,"phoneExt":25,"email":42},"Åsne S Holen, MSc","asho@kreftregisteret.no",[44],{"facility":45,"status":46,"city":47,"state":25,"zip":25,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Cancer Registry of Norway, Norwegian Institute of Public Health","RECRUITING","Oslo","Norway","NO",{"type":51,"coordinates":52},"Point",[53,54],10.74609,59.91273,{"lat":54,"lon":53},[57],{"name":32,"role":36,"phone":58,"phoneExt":25,"email":39},"+4722928828",{"type":60,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[62,64,66,69],{"name":63,"class":22},"Helse Vest",{"name":65,"class":22},"Helse Midt-Norge",{"name":67,"class":68},"Helse Nord","INDUSTRY",{"name":70,"class":22},"Norwegian Cancer Society","100518580","artificial-intelligence-in-mammography-screening-in-norway-100518580",false,"NCT06032390","Artificial Intelligence in Mammography Screening in Norway","Artificial Intelligence in BreastScreen Norway - a Randomized Controlled Trial","AIMS Norway","Inclusion Criteria:\n\n* Women attending the population-based mammography screening program BreastScreen Norway providing a signed, informed consent\n\nExclusion Criteria:\n\n* Women attending the population-based mammography screening program BreastScreen Norway not providing a signed, informed consent",true,"FEMALE","50 Years","69 Years",{"count":84,"type":85},150000,"ESTIMATED","INTERVENTIONAL",[88],"NA","The purpose of this randomized controlled trial is to compare the number of breast cancers detected among women who had their screening mammograms interpreted by artificial intelligence (AI) in combination with one or two breast radiologists to the number of breast cancers detected after standard independent double reading in BreastScreen Norway. The aims of the study is to prove that screening interpretation with AI in combination with one or two radiologists (the intervention) is non-inferior to standard interpretation procedure.",[91],"Breast Cancer",[93,94,95,96],"Breast Cancer Screening","Digital Mammography","Artificial Intelligence","Randomized Controlled Trial","2026-01-12",{"date":99,"type":100},"2026-01-14","ACTUAL",{"date":102,"type":100},"2024-11-25",{"date":104,"type":85},"2033-06",{"name":5,"class":6},1]