[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602320":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":32,"centralContacts":36,"locations":43,"responsibleParty":94,"collaborators":96,"id":99,"slug":100,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":41,"eligibilityCriteria":105,"healthyVolunteers":106,"sex":107,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":41,"studyType":113,"phases":114,"briefSummary":116,"conditions":117,"keywords":120,"overallStatus":59,"whyStopped":41,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"University of California, San Francisco","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Supplemental MRI","EXPERIMENTAL","Participants identified as Mirai high-risk on a negative\u002Fbenign screening mammogram will receive a supplemental MRI within 12 months of receiving a screening mammogram. Breast cancer risk following the Tyrer-Cuzick risk model will be assessed for comparison.",[13,14],"Procedure: Magnetic resonance imaging (MRI)","Device: Artificial Intelligence (AI)",[16,24],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"PROCEDURE","Magnetic resonance imaging (MRI)","Undergo Magnetic resonance (MR) imaging",[9],[22,23],"MRI","MRI Scan",{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DEVICE","Artificial Intelligence (AI)","AI applied to MRI images",[9],[30,31],"AI Models","AI Algorithm",[33],{"name":34,"affiliation":5,"role":35},"Maggie Chung, MD","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},"Tiffany Tran","CONTACT","877-827-3222",null,"tiffany.tran3@ucsf.edu",[44,58,74,84],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":41},"University of California, San Diego","NOT_YET_RECRUITING","San Diego","California","92093","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-117.16472,32.71571,{"lat":56,"lon":55},{"facility":5,"status":59,"city":60,"state":48,"zip":61,"country":50,"countryCode":51,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"RECRUITING","San Francisco","94143",{"type":53,"coordinates":63},[64,65],-122.41942,37.77493,{"lat":65,"lon":64},[68,69,71,72],{"name":38,"role":39,"phone":41,"phoneExt":40,"email":42},{"name":41,"role":39,"phone":41,"phoneExt":41,"email":70},"cancertrials@ucsf.edu",{"name":34,"role":35,"phone":41,"phoneExt":41,"email":41},{"name":73,"role":35,"phone":41,"phoneExt":41,"email":41},"Adam Yala, PhD",{"facility":75,"status":46,"city":76,"state":77,"zip":78,"country":50,"countryCode":51,"cosmosGeoPoint":79,"geoPoint":83,"contacts":41},"University of Chicago Comprehensive Cancer Center","Chicago","Illinois","60637",{"type":53,"coordinates":80},[81,82],-87.65005,41.85003,{"lat":82,"lon":81},{"facility":85,"status":59,"city":86,"state":87,"zip":88,"country":50,"countryCode":51,"cosmosGeoPoint":89,"geoPoint":93,"contacts":41},"University of Massachusetts Memorial Medical Center","Worcester","Massachusetts","01655",{"type":53,"coordinates":90},[91,92],-71.80229,42.26259,{"lat":92,"lon":91},{"type":95,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR",[97],{"name":98,"class":6},"Breast Cancer Research Foundation","100602320","mirai-mri-validation-of-ai-models-for-breast-cancer-risk-100602320",false,"NCT07121972","Mirai-MRI: Validation of AI Models for Breast Cancer Risk","Mirai-MRI: Multi-site Prospective Validation of AI Models for Breast Cancer Risk","Inclusion Criteria:\n\n1. All asymptomatic participants assigned female at birth, ages 40-89 years old with screening mammography assessed as Breast Imaging Reporting and Data System (BI-RADS) 1, BI-RADS 2, or initial BI-RADS 0 with subsequent diagnostic mammogram assessed as BI-RADS 1 or BI-RADS 2.\n2. Screening mammogram assessed as high-risk by Mirai (top 3 percentile of 2-year risk).\n3. Availability of a routine screening mammogram report, along with a subsequent diagnostic mammogram report if applicable, and access to the corresponding Digital Imaging and Communications in Medicine (DICOM) images.\n4. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Screening mammogram that is assessed as BI-RADS 0 for technical recall.\n2. Contraindications for MRI:\n\n   1. Metallic foreign body in the eye.\n   2. MRI unsafe implants and\u002For medical devices.\n   3. Adverse reaction to a (gadolinium-based) contrast agent in the past.\n   4. Pregnant women.\n   5. Claustrophobia.\n   6. Exceeds site specific size and\u002For weight limit for MRI.\n3. If the participant meets site-specific criteria for screening estimated glomerular filtration rate (eGFR) prior to MRI, participants with severely impaired renal function (GFR \\\u003C 30 mL\u002Fmin) will be excluded. According to University of California, San Francisco's policy for MRI with contrast (gadolinium-containing), serum creatinine with calculation of eGFR should be obtained within 6 weeks of the MRI study for participants with any of the following risk factors:\n\n   1. History of \"kidney disease\" as an adult, including renal tumor or transplant.\n   2. Diabetes treated with insulin or other prescribed medications.\n   3. Hypertension (high blood pressure) requiring medication.\n   4. Multiple myeloma.\n   5. Solid organ transplant.\n   6. History of severe hepatic disease\u002Fliver transplant\u002Fpending liver transplant.",true,"FEMALE","40 Years","89 Years",{"count":111,"type":112},400,"ESTIMATED","INTERVENTIONAL",[115],"NA","This is a multi-center, single arm trial to evaluate the cancer detection rate of supplemental screening magnetic resonance imaging (MRI) in participants who are high-risk by Mirai-MRI assessment. Mirai is an accurate cancer risk model based on full-resolution mammograms.",[118,119],"Cancer Risk","Breast Cancer Risk",[121,122],"Screening","BI-RADS","2025-11-04",{"date":125,"type":126},"2025-11-06","ACTUAL",{"date":128,"type":126},"2025-11-03",{"date":130,"type":112},"2027-01-31",{"name":5,"class":6},4]