[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553161":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":32,"locations":43,"responsibleParty":63,"collaborators":10,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":10,"enrollmentInfo":77,"targetDuration":10,"studyType":80,"phases":10,"briefSummary":81,"conditions":82,"keywords":10,"overallStatus":46,"whyStopped":10,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"University of Lausanne Hospitals","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Healthy volunteers for protocol optimization",null,"The commencement of the study involves the formulation of the 0.55T MRI protocol. For this purpose, a cohort of 23 male volunteers will undergo a 0.55T MRI. The objective is to achieve the same spatial resolution and coverage as observed at 3T.",[13],"Device: Siemens Magnetom Free.Max 0.55T (Siemens Healthineers, Erlangen, Germany).",{"label":15,"type":10,"description":16,"interventionNames":17},"Study of 0.55T Prostate MRI in Adult Men with Metal Implants.","The second phase of the research will be carried out to compare the MRI image quality between 0.55T and 3T MRI. The study will involve 20 adult men, who on 3T prostate MRI, have DWI reported as sub-diagnostic (PI-QUAL \\\u003C 3) due to the presence of metallic implant(s).",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Evaluation of 0.55T Prostate MRI in Adult Men with Suspicious Lesions.","The third phase includes 31 patients whose 3T MRIs detected lesions classified as PI-RADS 4\u002F5 and who are scheduled for targeted prostate biopsy.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":10},"DEVICE","Siemens Magnetom Free.Max 0.55T (Siemens Healthineers, Erlangen, Germany).","Performing low-field MRI to evaluate image quality with patients carrying metallic implants and assess the detection of suspicious prostate lesions.",[19,9,15],[29],{"name":30,"affiliation":5,"role":31},"Ileana Jelescu, Prof","STUDY_CHAIR",[33,39],{"name":34,"role":35,"phone":36,"phoneExt":37,"email":38},"Naïk Vietti-Violi, Dre","CONTACT","0795560240","+41","Naik-Vietti-Violi@chuv.ch",{"name":40,"role":35,"phone":41,"phoneExt":37,"email":42},"Gorun Ilanjian, Dr","0795560232","Gorun.Ilanjian@chuv.ch",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Lausanne University Hospital","RECRUITING","Lausanne","Canton of Vaud","1011","Switzerland","CH",{"type":53,"coordinates":54},"Point",[55,56],6.63282,46.516,{"lat":56,"lon":55},[59],{"name":60,"role":35,"phone":61,"phoneExt":10,"email":62},"Naïk Vietti Violi, MD","+41795560240","naik.vietti-violi@chuv.ch",{"type":64,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Naik Vietti Violi","Principal-Investigator, Executive Physician of Diagnostic And Interventional Radiology Department","100553161","accurate-prostate-cancer-following-using-low-field-mri-low-prism-100553161",false,"NCT06482489","Accurate Prostate Cancer Following Using Low-Field MRI (Low-PRISM)","Comparing Prostate Cancer Screening Between Standardized 3T MRI Screening Protocol and Low-Field MRI in a Prospective Study","Low-PRISM","Inclusion Criteria:\n\nWork Package1 (WP): 0.55T MRI Protocol Development\n\n* Healthy male volunteers aged 18 and above.\n* Agree to be contacted for incidental findings\n* Signed informed consent\n\nWP2: 0.55T Prostate MRI with patients with metallic implant(s)\n\n* Adult men (≥18 y.o) with 3T MRI reported as sub-diagnostic due to metallic implants\n* Signed informed Consent\n\nWP3: 0.55T Prostate MRI with patients with suspicious lesion(s)\n\n* Adult men (≥18 y.o)\n* PI-RADS 4\u002F5 lesions detected on 3T MRI, schedules for targeted biopsy\n* Signed informed consent\n\nExclusion Criteria:\n\nWP1: 0.55T MRI Protocol Development\n\n* Individuals with a history of prostate cancer\n* MR Contraindications as listed in the MR Safety Screening form\n\nWP2: 0.55T Prostate MRI with patients with metallic implant(s)\n\n* Contraindications as per MD instructions\n* Any condition making the patient unsuitable for the study\n* Refusal to be notified in case of incidental finding on the examination\n\nWP3: 0.55T Prostate MRI with patients with suspicious lesion(s)\n\n* Individuals with a history of prostate cancer.\n* Contraindications as per MD instructions\n* Any condition making the patient unsuitable for the study\n* Refusal to be notified in case of incidental finding on the examination","MALE","18 Years",{"count":78,"type":79},74,"ESTIMATED","OBSERVATIONAL","This study compares the effectiveness of low-field MRI (0.55T) with high-field MRI (3T) in prostate cancer screening and image quality. It consists of three phases: optimizing the low-field MRI protocol with healthy volunteers, evaluating image quality in patients with metallic artifacts (like hip prostheses), and assessing low-field MRI in patients with suspicious prostate lesions found on high-field MRI.",[83],"Prostate Cancer","2025-03-31",{"date":86,"type":87},"2025-04-03","ACTUAL",{"date":89,"type":87},"2024-11-01",{"date":91,"type":79},"2025-07-31",{"name":5,"class":6},1]