[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100562793":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":26,"responsibleParty":44,"collaborators":46,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":10,"enrollmentInfo":67,"targetDuration":70,"studyType":71,"phases":10,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":87,"whyStopped":10,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Gold Standard Phantoms","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single Group Males",null,"Men with clinically suspected prostate cancer and referred for prostate MRI with Likert\u002FPIRADS 3 or above and prior decision made to perform targeted biopsy.",[13],"Diagnostic Test: MRI",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DIAGNOSTIC_TEST","MRI","Standard MRI using phantom.",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Lucy Newton","CONTACT","0044 7745627050","lucy.newton@goldstandardphantoms.com",[27],{"facility":28,"status":10,"city":29,"state":29,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"University College Hospital","London","WC1E 6AG","United Kingdom","UK",{"type":34,"coordinates":35},"Point",[36,37],-0.12574,51.50853,{"lat":37,"lon":36},[40],{"name":41,"role":23,"phone":42,"phoneExt":10,"email":43},"Harbir Sidhu","0044 7946610486","harbir.sidhu@nhs.net",{"type":45,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[47,50,52,55],{"name":48,"class":49},"Bioxydyn Ltd, Manchester","UNKNOWN",{"name":51,"class":49},"National Cancer Imaging Translational Accelerator",{"name":53,"class":54},"University College London Hospitals","OTHER",{"name":56,"class":49},"National Hospital of Neurology and Neurosurgery, Queens Square, London, UK","100562793","prostate-cancer-enhanced-diagnosis-by-calibration-technology-100562793",false,"NCT06607783","PRostate Cancer Enhanced Diagnosis by Calibration Technology","A Multi-Centre, Pivotal Stage, Study to Determine the Between MRI Scanner Reproducibility of Gold Standard Phantom Calibrated Acquisition Replicator (CARE) for Measurement of Apparent Diffusion Coefficients in the Prostate of Patients With MR Positive Lesions Destined for Biopsy","PREDICT","Inclusion Criteria:\n\n* Men aged 18 years and older undergoing investigations for PCa.\n* Standard of Care MRI conducted.\n* One or more lesions with a Likert score of 3 or above identified on clinical reports.\n* Planned targeted biopsy within 6 months from the date of clinical care MRI.\n* Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n* Prostate specific antigen (PSA) level \\> 20ng\u002Fml within 6 months\n* Previous diagnosis of prostate cancer\n* Ongoing hormone treatment within 3 months prior to MRI, excluding antiandrogens or 5-alpha reductase inhibitors\n* Contraindication to MRI scan","MALE","18 Years",{"count":68,"type":69},66,"ESTIMATED","3 Months","OBSERVATIONAL","The CARE® Phantom system is a medical device system that is being developed has been designed to enable the quantitative measurement of the apparent diffusion coefficient (ADC) in the prostate of patients undergoing a multi-parametric MRI (mpMRI) scan to detect prostate cancer. The final device system will comprise three elements: a calibration mat containing phantoms and embedded monitoring software, a docking station to transfer data from the phantoms, and software as a medical device (SaMD) for calibrating the resulting mpMRI images.\n\nIn this clinical trial, patients will undergo MRI scanning in different scanners using the GSP Phantoms to provide mpMRI images and phantom data for subsequent in silico analysis. The captured images and data will be used to further develop and calibrate the GSP prototype SaMD part of the medical device system, and to establish the degree of optimised reproducibility that can be achieved.",[74],"Prostate Cancers",[17,76,77,78,79,80,81,82,83,84,85,86],"Calibration","Prostate Cancer","Quantitative Imaging Biomarker","Reproducibility","Data interoperability","Phantom","Apparent Diffusion Coefficient","ADC","PIRAD","Diagnosis","Biopsy","NOT_YET_RECRUITING","2025-08-22",{"date":90,"type":91},"2025-08-28","ACTUAL",{"date":93,"type":69},"2025-09",{"date":95,"type":69},"2026-12",{"name":5,"class":6},1]