[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100467651":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":13,"centralContacts":18,"locations":27,"responsibleParty":82,"collaborators":84,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":96,"acronym":7,"eligibilityCriteria":97,"healthyVolunteers":94,"sex":98,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":7,"studyType":104,"phases":7,"briefSummary":105,"conditions":106,"keywords":7,"overallStatus":30,"whyStopped":7,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"University of Hawaii","OTHER",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DIAGNOSTIC_TEST","q3CB","The q3CB\u002FncCEM\u002FDBT acquisition protocol consists of a combination of DBT volume reconstructions and projection dual-energy mammograms acquired with a clinical contrast enhanced mammography (CEM) protocol, without contrast administration agent.",[14],{"name":15,"affiliation":16,"role":17},"John A Shepherd, PhD","University of Hawaii Cancer Research Center","PRINCIPAL_INVESTIGATOR",[19,23],{"name":15,"role":20,"phone":21,"phoneExt":7,"email":22},"CONTACT","808-440-5234","johnshep@hawaii.edu",{"name":24,"role":20,"phone":25,"phoneExt":7,"email":26},"Leila Kazemi","808-440-5231","lkazemi@hawaii.edu",[28,51,66],{"facility":29,"status":30,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"H. Lee Moffitt Cancer Center & Research Institute, Inc.","RECRUITING","Tampa","Florida","33612","United States","US",{"type":37,"coordinates":38},"Point",[39,40],-82.45843,27.94752,{"lat":40,"lon":39},[43,47,49],{"name":44,"role":20,"phone":45,"phoneExt":7,"email":46},"Emily Research Services Project Coordinator","813-745-5501","emily.amato@moffitt.org",{"name":48,"role":17,"phone":7,"phoneExt":7,"email":7},"Bethany L Niell, MD",{"name":50,"role":17,"phone":7,"phoneExt":7,"email":7},"Dana K Ataya, MD",{"facility":52,"status":30,"city":53,"state":54,"zip":55,"country":34,"countryCode":35,"cosmosGeoPoint":56,"geoPoint":60,"contacts":61},"Hawaii Radiology Associates, LTD (East Hawaii Women's Imaging Center)","Hilo","Hawaii","96720",{"type":37,"coordinates":57},[58,59],-155.09073,19.72991,{"lat":59,"lon":58},[62,65],{"name":63,"role":20,"phone":64,"phoneExt":7,"email":7},"Scott Grosskreutz, MD","808-935-1825",{"name":63,"role":17,"phone":7,"phoneExt":7,"email":7},{"facility":67,"status":30,"city":68,"state":54,"zip":69,"country":34,"countryCode":35,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"The Queen's Medical Center","Honolulu","96822",{"type":37,"coordinates":71},[72,73],-157.85833,21.30694,{"lat":73,"lon":72},[76,80],{"name":77,"role":20,"phone":78,"phoneExt":7,"email":79},"Richmond Clinical Research Associate","808-691-7609","riwong@queens.org",{"name":81,"role":17,"phone":7,"phoneExt":7,"email":7},"Todd Seto, MD",{"type":83,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR",[85,87,89],{"name":86,"class":6},"H. Lee Moffitt Cancer Center and Research Institute",{"name":88,"class":6},"Queen's Medical Center",{"name":90,"class":91},"Hawaii Radiologic Associates, Ltd.","UNKNOWN","100467651","lesion-composition-and-quantitative-imaging-analysis-on-breast-cancer-diagnosis-100467651",false,"NCT05369546","Lesion Composition and Quantitative Imaging Analysis on Breast Cancer Diagnosis","Inclusion Criteria:\n\n* Had a recent diagnostic mammogram with a BI-RADS diagnostic score 4 or 5 assigned by a radiologist (BIRADS are standardized mammography assessment categories: 4 is for \"Suspicious abnormality\", 5 is for \"Highly suggestive of malignancy\".\n* Have not had biopsy\n\nExclusion Criteria:\n\n* Pregnant or breast feeding\n* History of breast cancer or a mastectomy (removal of the breast) with Systemic Therapy (ex. Chemotherapy, hormones and hormone inhibitors, etc.).","FEMALE","20 Years","85 Years",{"count":102,"type":103},600,"ESTIMATED","OBSERVATIONAL","The objective is to better identify suspicious breast lesions that need to be biopsied for malignancy in women currently recommended for biopsy. The long-term goal is to reduce unnecessary biopsies and increase biopsy yield. To do this, the investigators have developed an innovative way to use FDA-approved breast imaging protocols to acquire multispectral images to measure the composition of suspicious breast lesions. The central hypothesis is that breast tissue composition in combination with analysis of morphological and textural tissue characteristics on digital breast tomosynthesis (DBT) imaging will yield significantly higher breast cancer specificity than conventional interpretation of DBT alone.",[107],"Breast Cancer","2023-01-31",{"date":110,"type":111},"2023-02-02","ACTUAL",{"date":113,"type":111},"2022-08-01",{"date":115,"type":103},"2026-07",{"name":5,"class":6},3]