[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100468803":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":27,"locations":35,"responsibleParty":56,"collaborators":20,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":62,"acronym":20,"eligibilityCriteria":63,"healthyVolunteers":60,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":20,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":78,"overallStatus":38,"whyStopped":20,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Northwell Health","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Bi-parametric Screening MRI","EXPERIMENTAL","Bi-parametric MRI to be administered to High Risk males",[13],"Diagnostic Test: Bi-parametric MRI",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DIAGNOSTIC_TEST","Bi-parametric MRI","When used for the evaluation of prostate cancer, MRI typically involves multiple sequences and typically includes typical T1 and T2 phases with the addition of diffusion weighted imaging and dynamic contrast enhanced imaging. In this study, we have decided to omit dynamic contrast enhanced imaging due to its decreased diagnostic yield relative to T2 and DWI and associated increased risk of contrast agents, this is a common approach for prostate cancer screening and is referred to as a bi-parametric MRI",[9],null,[22,25],{"name":23,"affiliation":5,"role":24},"Ardeshir Rastinehad, DO","PRINCIPAL_INVESTIGATOR",{"name":26,"affiliation":5,"role":24},"Manish Vira, MD",[28,33],{"name":29,"role":30,"phone":31,"phoneExt":20,"email":32},"Cynthia Knauer, RN","CONTACT","516-734-8500","urologyresearch@northwell.edu",{"name":34,"role":30,"phone":31,"phoneExt":20,"email":32},"Monica Johnson",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Cynthia Knauer","RECRUITING","Lake Success","New York","11042","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-73.71763,40.77066,{"lat":48,"lon":47},[51,52,54,55],{"name":37,"role":30,"phone":31,"phoneExt":20,"email":32},{"name":34,"role":30,"phone":31,"phoneExt":20,"email":53},"urologyresesearch@northwell.edu",{"name":23,"role":24,"phone":20,"phoneExt":20,"email":20},{"name":26,"role":24,"phone":20,"phoneExt":20,"email":20},{"type":57,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100468803","utility-of-biparametric-mri-magnetic-resonance-imaging-as-a-screening-tool-for-prostate-cancer-in-a-high-risk-cohort-100468803",false,"NCT05384535","Utility of Biparametric MRI (Magnetic Resonance Imaging) as a Screening Tool for Prostate Cancer in a High-Risk Cohort","Inclusion Criteria:\n\n1. PSA between 1.0 and 2.5 ng\u002FdL\n2. High risk for prostate cancer, i.e. Black or they have a first degree relative with history of prostate cancer (father, brother) or specific genetic syndromes i.e. BRCA 1\u002F2, HOX B13, Lynch syndrome, ATM, CHEK2\n3. Patient is willing to participated in prostate cancer screening\n4. Patient is capable of giving informed consent\n\nExclusion Criteria:\n\n1. Nodularity or firmness of prostate on exam\n2. Patient has undergone a prior biopsy or prostate surgery\n3. Patient is taking 5-alpha reductase inhibitors to manage benign prostatic hyperplasia, as this can significantly alter PSA levels.\n4. Patient has a history of UTI or prostatitis in the preceding 6 months, as this can significantly alter PSA levels.\n5. Patient has a contraindication to MRI, these include but are not limited to pacemakers, neurostimulator devices, metal cardiac valves, certain tattoos, or foreign bodies\n6. Participants that experience claustrophobia, anxiety and\u002For vertigo when moved inside the scanner\n7. The participant cannot tolerate lying flat for the study duration","MALE","40 Years","55 Years",{"count":68,"type":69},100,"ESTIMATED","INTERVENTIONAL",[72],"NA","To determine whether using bpMRI in subjects who are at high risk of developing prostate cancer in conjunction with PSA will improve prostate cancer screening protocols.",[75,76,77],"Prostate Cancer","Magnetic Resonance Imaging","Population at Risk",[75,79,76],"Screening","2025-11-19",{"date":82,"type":83},"2025-11-24","ACTUAL",{"date":85,"type":83},"2022-08-15",{"date":87,"type":69},"2028-10-31",{"name":5,"class":6},1]