[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551624":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":29,"centralContacts":34,"locations":41,"responsibleParty":58,"collaborators":39,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":39,"eligibilityCriteria":66,"healthyVolunteers":67,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":39,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":39,"overallStatus":44,"whyStopped":39,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Anhui Provincial Hospital","OTHER_GOV",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"[18F]F-PSMA-N5 and [68Ga]Ga-PSMA-11 PET\u002F CT scan","EXPERIMENTAL","Subjects PET\u002FCT imaging: On any two days for two consecutive weeks, each subject underwent a PET\u002F CT scan after intravenous injection of \\[18F\\]F-PSMA-N5 and \\[68Ga\\]Ga-PSMA-11.",[13,14],"Drug: [18F]F-PSMA-N5","Drug: [68Ga]Ga-PSMA-11",[16,23],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","[18F]F-PSMA-N5","Each subject receive a single intravenous injection of \\[18F\\]F-PSMA-N5, and undergo PET\u002FCT imaging within the specificed time.",[9],[22],"[18F]F-PSMA-N5 injection",{"type":17,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"[68Ga]Ga-PSMA-11","Each subject receive a single intravenous injection of \\[68Ga\\]Ga-PSMA-11, and undergo PET\u002FCT imaging within the specificed time.",[9],[28],"[68Ga]Ga-PSMA-11 injection",[30],{"name":31,"affiliation":32,"role":33},"Qiang Xie","The First Affiliated Hospital of USTC (Anhui Provincial Hospital)","STUDY_CHAIR",[35],{"name":36,"role":37,"phone":38,"phoneExt":39,"email":40},"Qiang Xie, MD","CONTACT","+8613721108043",null,"xieqiang1980@ustc.edu.cn",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"The First Affiliated Hospital of China University of Science and Technology（Anhui Provincial Hospital）","RECRUITING","Hefei","Anhui","230000","China","CN",{"type":51,"coordinates":52},"Point",[53,54],117.28083,31.86389,{"lat":54,"lon":53},[57],{"name":36,"role":37,"phone":38,"phoneExt":39,"email":40},{"type":59,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR","100551624","early-phase-1-head-to-head-comparison-of-18ff-psma-n5-with-68gaga-psma-11-petct-in-pca-diagnosis-recurrence-and-metastasis-100551624",false,"NCT06462508","Head-to-head Comparison of [18F]F-PSMA-N5 With [68Ga]Ga-PSMA-11 PET\u002FCT in PCa Diagnosis, Recurrence, and Metastasis","Head-to-head Comparison of [18F]F-PSMA-N5 With [68Ga]Ga-PSMA-11 PET\u002FCT in Prostate Cancer Diagnosis, Recurrence, and Metastasis: a Prospective Study","Inclusion Criteria:\n\n* Aged from 18 to 90 years old;\n* Complete MRI images and clinical data (such as PSA level, Gleason grade, etc.);\n* Prostate cancer detected by PSA or imaging examination, or clinically suspected recurrence after standardized treatment;\n* simultaneous \\[18F\\]F-PSMA-N5 and \\[68Ga\\]Ga-PSMA-11 examinations within two weeks;\n* Willing to undergo surgery or needle biopsy for pathological examination after examination, or confirmed as prostate cancer by histopathology before or after treatment;\n* Sign informed consent.\n\nExclusion Criteria:\n\n* Patients who cannot cooperate with the examination;\n* Concurrent malignant tumors;\n* Previous alcohol allergy;\n* Patients with liver and kidney dysfunction;\n* Other circumstances deemed by the investigator to be inappropriate for trial participation.",true,"MALE","18 Years","90 Years",{"count":72,"type":73},30,"ESTIMATED","INTERVENTIONAL",[76],"EARLY_PHASE1","To prospectively evaluate the radiodrug biodistribution of a novel PET imaging agent \\[18F\\]F-PSMA-N5 in different organs of prostate cancer patients and its diagnostic efficacy in the diagnosis, recurrence and metastasis of prostate cancer, and to compare with \\[68Ga\\]Ga-PSMA-11.",[79,80],"Prostate Cancer","PET\u002FCT","2024-06-12",{"date":83,"type":84},"2024-06-17","ACTUAL",{"date":86,"type":84},"2024-04-20",{"date":88,"type":73},"2025-12-31",{"name":5,"class":6},1]