[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601760":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":28,"centralContacts":32,"locations":41,"responsibleParty":59,"collaborators":61,"id":68,"slug":27,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":27,"enrollmentInfo":77,"targetDuration":27,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":90,"overallStatus":99,"whyStopped":27,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Smart Breast Corp.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Breast screening","ACTIVE_COMPARATOR","Screening DBT and screening MBI are compared in women with dense breasts. Then, DBT-guided biopsy and MBI-guided biopsy are compared.",[13,14],"Device: Molecular Breast Imaging","Device: MBI-guided biopsy",[16,23],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DEVICE","Molecular Breast Imaging","MBI is a molecular imaging (nuclear medicine) technique using a low dose i.v. radiopharmaceutical injection and solid-state gamma cameras to image the breast, where cancer mitochondria avidly take up the radiopharmaceutical.",[9],[22],"MBI",{"type":17,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"MBI-guided biopsy","Two stereotactic MBI views of the breast produce a precise 3D location for each lesion targeted for biopsy. A vacuum-assisted core biopsy needle is guided to the lesion position.",[9],null,[29],{"name":30,"affiliation":5,"role":31},"James W Hugg, PhD","PRINCIPAL_INVESTIGATOR",[33,37],{"name":30,"role":34,"phone":35,"phoneExt":27,"email":36},"CONTACT","724-584-3266","James.Hugg@SmartBreast.com",{"name":38,"role":34,"phone":39,"phoneExt":27,"email":40},"Bradley E Patt, PhD","818-645-4081","Brad.Patt@SmartBreast.com",[42],{"facility":43,"status":27,"city":44,"state":45,"zip":46,"country":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"University of Texas Southwestern Medical Center","Dallas","Texas","75390","United States",{"type":49,"coordinates":50},"Point",[51,52],-96.80667,32.78306,{"lat":52,"lon":51},[55],{"name":56,"role":34,"phone":57,"phoneExt":27,"email":58},"Radiology Clinical Research Manager","214-648-7754","Charlton.Starcke@UTSouthwestern.edu",{"type":60,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR",[62,65],{"name":63,"class":64},"University of Texas, Southwestern Medical Center at Dallas","OTHER",{"name":66,"class":67},"National Cancer Institute (NCI)","NIH","100601760",false,"NCT07114679","Molecular Breast Imaging (MBI)-Guided Biopsy","Molecular Breast Imaging (MBI)-Guided Biopsy Pilot SBIR","MBI-GB-Pilot","Inclusion Criteria:\n\n* dense breasts (BI-RADS C or D) on screening DBT\n\nExclusion Criteria:\n\n* pregnancy","FEMALE","21 Years",{"count":78,"type":79},250,"ESTIMATED","INTERVENTIONAL",[82],"NA","The goal of this pilot clinical trial is to demonstrate supplemental screening MBI (molecular breast imaging) in women with dense breasts. The main questions it aims to answer are:\n\n* Does screening MBI find more cancer than screening DBT (3D mammography, digital breast tomosynthesis?\n* Does screening MBI result in more call-backs for biopsy than DBT?\n* How well does MBI-guided biopsy conform with pathology reports?\n\nResearchers will compare screening MBI to screening DBT to see if MBI is more sensitive to detecting cancer in women with dense breasts.\n\nParticipants will\n\n* Receive both screening DBT and screening MBI\n* Receive either DBT-guided or MBI-guided biopsy (randomly assigned), if required by the screening images",[85,86,87,88,89],"Breast Cancer Detection","Breast Neoplasm","Molecular Imaging","Biopsy","Dense Breasts",[91,92,93,94,95,96,97,22,98],"screening","crossover","single-group","pilot","biopsy","randomized assignment","dense breasts","molecular imaging","NOT_YET_RECRUITING","2025-08-03",{"date":102,"type":103},"2025-08-11","ACTUAL",{"date":105,"type":79},"2027-06",{"date":107,"type":79},"2028-06",{"name":5,"class":6},1]