[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601760":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":28,"centralContacts":32,"locations":41,"responsibleParty":60,"collaborators":62,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":27,"enrollmentInfo":79,"targetDuration":27,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":92,"overallStatus":101,"whyStopped":27,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"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,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"University of Texas Southwestern Medical Center","Dallas","Texas","75390","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-96.80667,32.78306,{"lat":53,"lon":52},[56],{"name":57,"role":34,"phone":58,"phoneExt":27,"email":59},"Radiology Clinical Research Manager","214-648-7754","Charlton.Starcke@UTSouthwestern.edu",{"type":61,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR",[63,66],{"name":64,"class":65},"University of Texas, Southwestern Medical Center at Dallas","OTHER",{"name":67,"class":68},"National Cancer Institute (NCI)","NIH","100601760","molecular-breast-imaging-mbi-guided-biopsy-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":80,"type":81},250,"ESTIMATED","INTERVENTIONAL",[84],"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",[87,88,89,90,91],"Breast Cancer Detection","Breast Neoplasm","Molecular Imaging","Biopsy","Dense Breasts",[93,94,95,96,97,98,99,22,100],"screening","crossover","single-group","pilot","biopsy","randomized assignment","dense breasts","molecular imaging","NOT_YET_RECRUITING","2025-08-03",{"date":104,"type":105},"2025-08-11","ACTUAL",{"date":107,"type":81},"2027-06",{"date":109,"type":81},"2028-06",{"name":5,"class":6},1]