[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100539053":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":13,"locations":7,"responsibleParty":22,"collaborators":7,"id":26,"slug":27,"hasResults":28,"nctId":29,"briefTitle":30,"officialTitle":31,"acronym":7,"eligibilityCriteria":32,"healthyVolunteers":28,"sex":33,"minAge":34,"maxAge":35,"enrollmentInfo":36,"targetDuration":7,"studyType":39,"phases":7,"briefSummary":40,"conditions":41,"keywords":7,"overallStatus":43,"whyStopped":7,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":7},{"fullName":5,"class":6},"IRCCS San Raffaele","OTHER",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DEVICE","AURA10® Specimen PET\u002FCT imager","The AURA10 PET-CT specimen imager detects and measures the electron density distribution of a specimen and the radiotracer distribution within a specimen. The function of the system is to acquire and visualize PET and CT images of a specimen, based on which a healthcare professional can rapidly verify whether the correct tissue has been resected. It can be used in any condition that requires resection surgery to visualize the resected specimen. The device is automated and semi-quantitative, i.e., qualitative regarding visualization of structure and radiotracer distribution and quantitative regarding tissue density (Hounsfield units) and radiotracer uptake in the specimen (Bq\u002Fml). The type of specimen required is resected tissue from a patient undergoing resection surgery.",[14,19],{"name":15,"role":16,"phone":17,"phoneExt":7,"email":18},"GIORGIO GANDAGLIA","CONTACT","+39 02 26438068","gandaglia.giorgio@hsr.it",{"name":20,"role":16,"phone":7,"phoneExt":7,"email":21},"LUCIA DAMBROSIO","dambrosio.lucia@hsr.it",{"type":23,"investigatorFullName":24,"investigatorTitle":25,"investigatorAffiliation":5,"oldNameTitle":7,"oldOrganization":7},"PRINCIPAL_INVESTIGATOR","Giorgio Gandaglia","Assistant Professor","100539053","high-resolution-intra-operative-psma-pet-ct-in-prostate-cancer-100539053",false,"NCT06298838","High-resolution Intra-operative PSMA PET-CT in Prostate Cancer","Perioperative Assessment of Intraoperative Margins and Lymph Node Invasion Using High-resolution 18F-PSMA-PET-CT in Prostate Cancer: a Pilot Study","Inclusion Criteria:\n\n1. Male patient, 18 years of age or older.\n2. Patient is confirmed with high risk prostate cancer.\n3. Patient is indicated to undergo radical prostatectomy and ePLND.\n4. Patient is estimated compliant for study participation by the investigator.\n5. Patient has freely given his\u002Fher informed consent to participate in this study.\n\nExclusion Criteria:\n\n1. Patient has general or local contra-indications for radical prostatectomy.\n2. Patient has active viral or fungal infection.\n3. Patient previously received radiotherapy of the prostate.\n4. Patient participated in other clinical studies with radiation exposure of more than 1 mSv in the past year.","MALE","18 Years","80 Years",{"count":37,"type":38},10,"ESTIMATED","OBSERVATIONAL","This is a Single-center, diagnostic open-label prospective, pilot study in a total of 10 patients affected by Prostate cancer (PCa) with a risk of lymph node invasion (LNI) higher than 5% and candidates for a robot-assisted radical prostatectomy (RARP) with an extended pelvic lymph node dissection (ePLND) .\n\nThe aim of the trial is to evaluate the feasibility and accuracy and clinical value of a novel high-resolution perioperative PET-CT-scan for intraoperative margin and lymph node invasion assessment, after 18F-PSMA injection, using histopathology as the gold standard.",[42],"Prostate Cancer","NOT_YET_RECRUITING","2026-05-14",{"date":46,"type":47},"2026-05-18","ACTUAL",{"date":49,"type":38},"2026-06",{"date":51,"type":38},"2027-05",{"name":5,"class":6}]