[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100539342":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":30,"responsibleParty":47,"collaborators":50,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":20,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":20,"enrollmentInfo":66,"targetDuration":20,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":32,"whyStopped":20,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Brigham and Women's Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"MRI-guided prostate biopsy","EXPERIMENTAL","Participants who receive biopsy under MRI-guidance and a needle holder frame.",[13],"Device: MRI-guided prostate biopsy using the needle holder frame.",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","MRI-guided prostate biopsy using the needle holder frame.","A needle holding frame will be used during a routine MRI-guided prostate biopsy procedure, where tissue samples are obtained from each suspected region found on MRI using an MRI-conditional core biopsy needle. In this routine procedure, tissue sampling is performed in an MRI gantry and intraprocedural MRI is used to localize the regions.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Kemal Tuncali, MD","PRINCIPAL_INVESTIGATOR",[26],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","(617) 732-7631","ktuncali@bwh.harvard.edu",[31],{"facility":5,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"RECRUITING","Boston","Massachusetts","02115","United States","US",{"type":39,"coordinates":40},"Point",[41,42],-71.05977,42.35843,{"lat":42,"lon":41},[45],{"name":23,"role":27,"phone":46,"phoneExt":20,"email":29},"617-732-7631",{"type":24,"investigatorFullName":48,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Kemal Tuncali, M.D.","Assistant Professor of Radiology",[51,54],{"name":52,"class":53},"National Cancer Institute (NCI)","NIH",{"name":55,"class":56},"Physical Sciences Inc.","UNKNOWN","100539342","mri-guided-prostate-biopsy-100539342",false,"NCT06302595","MRI Guided Prostate Biopsy","Magnetic Resonance Imaging Guided Prostate Biopsy","Inclusion Criteria:\n\n* Either an abnormal serum prostate-specific antigen (PSA) level (\\> 4ng\u002FMl) or a palpable nodule in the prostate on digital rectal examination or prostate MRI suspicious lesion..\n* Diagnostic MRI of the prostate gland.\n* Age \\> 30 years\n* Signed informed consent.\n* No contra-indications to MRI, i.e. no cardiac pacemaker.\n* No recent or ongoing active ischemic heart disease.\n\nExclusion Criteria:\n\n* Inability to give informed consent.\n* Contra-indications to MRI- cardiac pacemaker, inner ear implants, non-MR compatible intracranial aneurysm clips.\n* Recent or ongoing active ischemic heart disease such as recent or ongoing angina.","MALE","30 Years",{"count":67,"type":68},15,"ESTIMATED","INTERVENTIONAL",[71],"NA","This study aims to assess the feasibility of magnetic resonance (MR) guided prostate biopsy using a needle holder frame. This frame is used to help position the needle used for the biopsy. The feasibility in this study is defined as whether the needle holder frame enables accurate tissue sampling from a suspicious region in the prostate found on an MR image. If it does, a biopsy can be carried out with the needle holder frame safely in a clinical routine. The study will be conducted during a routine MR-guided prostate biopsy procedure with an investigational needle holder frame instead of a conventional needle-guiding template.",[74],"Suspected Prostate Cancer",[76,77,78,79],"prostate cancer","prostate biopsy","MR-guided prostate biopsy","targeted biopsy","2025-12-01",{"date":82,"type":83},"2025-12-03","ACTUAL",{"date":85,"type":83},"2023-08-24",{"date":87,"type":68},"2026-06",{"name":5,"class":6},1]