[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653246":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":24,"studyPopulation":17,"armGroups":25,"interventions":32,"overallOfficials":38,"centralContacts":49,"locations":54,"responsibleParty":72,"collaborators":17,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":17,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":17,"enrollmentInfo":83,"targetDuration":17,"studyType":86,"phases":87,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":98,"whyStopped":17,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Sunnybrook Health Sciences Centre","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"Aiding the detection of prostate cancer","To determine whether MT\u002FCEST MRI can aid in the detection of prostate cancer. The histopathological detection of cancer in biopsy cores will serve as a measure of outcome to which the MT\u002FCEST MRI parameter and relaxation images will be compared.","1 year",[14],{"measure":15,"description":16,"timeFrame":12},"Aiding risk stratification and the decision whether targeted prostate biopsy is justified","To determine whether MT\u002FCEST MRI can aid multiparametric MRI (mpMRI) in risk stratification and to decide whether targeted prostate biopsy is justified. The presence of cancer detected histopathologically in biopsy locations suggested by MT\u002FCEST MRI, but not chosen for biopsy by convention mpMRI will serve as a measure of outcome.",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":17,"primaryPurpose":21,"observationalModel":17,"timePerspective":17,"maskingInfo":22},"NA","SINGLE_GROUP","DIAGNOSTIC",{"masking":23,"maskingDescription":17,"whoMasked":17},"NONE","Prostate Imaging and Data Reporting System assessment categories positively correlate with an increased likelihood of detecting clinically significant prostate cancer (csPCa) at targeted biopsy1. A PI-RADS assessment category 3 (intermediate, clinically significant cancer likelihood equivocal) lesion is often not csPCa. Studies evaluating the likelihood of csPCa cancer at targeted biopsy of PI-RADS category 3 lesions have reported variable rates of PCa diagnosis, ranging from 5-30%, with the majority of studies showing a relatively low likelihood of eventual csPCa diagnosis2-4. Management of PI-RADS category 3 lesion is variable, ranging from immediate biopsy to surveillance5,6. Given the disparity in management patterns for PI-RADS category 3 lesions and a small but not insignificant proportion of these lesions harboring csPCa, better classification of category 3 lesion is an unmet need. Previous studies in these patients have shown a correlation of csPCa with older patient age, smaller prostate volumes, higher prostate-specific antigen density (PSAD), and increased clinical stage7-11.\n\nIn this study, we will investigate the ability of magnetization transfer (MT) and chemical exchange saturation transfer (CEST) magnetic resonance imaging (MRI), without the use of any injected contrast agent, in conjunction with multiparametric magnetic resonance imaging (mpMRI) to aid in the detection of cancer, risk stratification and to decide whether a targeted prostate biopsy is justified. In this study, we propose to use the following ST-MRI techniques:\n\n1. Chemical Exchange Saturation Transfer (CEST) to probe changes in tumour metabolism.\n2. Magnetization Transfer (MT) to evaluate tumour environment microstructure.\n\nUp to five healthy volunteers will be recruited for ST-MRI testing and estimation of test\u002Fre-test reproducibility. Testing of MR imaging protocols on healthy volunteers (without contrast agent) is required for optimization of sequence parameters including: higher signal intensity, higher contrast between tissue types, decreased scan time, and reduced image artifacts. There will be up to three MRI scans per healthy volunteer. MRI contrast agent will not be injected.\n\nPatient recruitment will be performed at the Odette Cancer Centre. There will be one MRI scan per patient. All patients will undergo ST-MRI scans at Sunnybrook. ST-MRI parameter images including MTR, AREX, and quantitative MT model parameters, in addition to quantitative magnetization relaxation images will be used to identify areas of prostate with altered image contrast. Other quantitative and semiquantitative features will also be evaluated from the images. We hypothesize that ST-MRI will identify cancer suspicious areas that overlap with those identified by mpMRI and potentially additional areas.",[26],{"label":27,"type":28,"description":29,"interventionNames":30},"Diagnostic Test: Saturation Transfer (ST)-MRI","EXPERIMENTAL","Non-contrast magnetic resonance imaging \"Saturation Transfer\" scans consisting of magnetization transfer (MT) and chemical exchange saturation transfer (CEST)",[31],"Procedure: Biopsy-Guided Therapy Selection",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":17},"PROCEDURE","Biopsy-Guided Therapy Selection","Saturation transfer MRI (chemical exchange saturation transfer and magnetization transfer) used to identify two additional biopsy locations in addition to those identified by conventional MRI.",[27],[39,43,45,47],{"name":40,"affiliation":41,"role":42},"Greg J Stanisz, PhD","Sunnybrook Research Institute","PRINCIPAL_INVESTIGATOR",{"name":44,"affiliation":5,"role":42},"Christopher Lim, MD",{"name":46,"affiliation":5,"role":42},"Danny Vesprini, MSc, MD",{"name":48,"affiliation":5,"role":42},"Stanley K Liu, MD, PhD",[50],{"name":40,"role":51,"phone":52,"phoneExt":17,"email":53},"CONTACT","416-480-5725","greg.stanisz@utoronto.ca",[55],{"facility":5,"status":17,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Toronto","Ontario","M4N 3M5","Canada","CA",{"type":62,"coordinates":63},"Point",[64,65],-79.39864,43.70643,{"lat":65,"lon":64},[68,69,70,71],{"name":40,"role":42,"phone":17,"phoneExt":17,"email":17},{"name":44,"role":42,"phone":17,"phoneExt":17,"email":17},{"name":46,"role":42,"phone":17,"phoneExt":17,"email":17},{"name":48,"role":42,"phone":17,"phoneExt":17,"email":17},{"type":73,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR","100653246","cest-for-prostate-biopsy-100653246",false,"NCT07785024","CEST for Prostate Biopsy","Advanced Metabolic MRI to Refine Targeted Prostate Biopsy","Inclusion Criteria:\n\n* PI-RADS category 3 prostate cancer with upcoming targeted biopsy\n\nExclusion Criteria:\n\n* Contraindications to MRI\n* Prior radiotherapy\n* Prior chemotherapy\n* Prior prostate biopsy","MALE","18 Years",{"count":84,"type":85},20,"ESTIMATED","INTERVENTIONAL",[19],"Samples of prostate tissue acquired by biopsy to determine whether there is cancer will sometimes not find cancer that is present. Conventionally, magnetic resonance imaging (MRI) is used to identify 12 areas to biopsy. We will use an advanced MRI method called magnetization transfer (MT) and chemical exchange saturation transfer (CEST) imaging to suggest two additional biopsy location. Our objectives are to determine 1) whether MT\u002FCEST MRI can aid in the detection prostate cancer and 2) whether MT\u002FCEST MRI can aid conventional MRI in risk stratification and to decide whether targeted prostate biopsy is justified.",[90],"Prostate Cancer Detection",[92,93,94,95,96,97],"biopsy","MRI","saturation transfer","PI-RADS","chemical exchange saturation transfer","magnetization transfer","NOT_YET_RECRUITING","2026-08-19",{"date":101,"type":102},"2026-08-25","ACTUAL",{"date":104,"type":85},"2026-09",{"date":106,"type":85},"2027-09",{"name":5,"class":6},1]