[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643370":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":18,"centralContacts":19,"locations":28,"responsibleParty":60,"collaborators":63,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":18,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":18,"enrollmentInfo":78,"targetDuration":18,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":93,"whyStopped":18,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Hoag Memorial Hospital Presbyterian","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Cu-NU101","EXPERIMENTAL","Subjects will receive a single dose of 61Cu-NU101, administered as a slow intravenous bolus over 10 seconds, with a dosage of 148 MBq (4 mCi) +\u002F-10% , followed by PET\u002FCT imaging 1 hour (+\u002F- 10 minutes) and 4 hours (+\u002F- 30 minutes) post radiotracer administration. There are no specific restrictions that should apply when administering 61Cu-NU101. There will be optional 5-minute dynamic scans at tracer administration and 20- and 40-minutes post injection.",[13],"Drug: Cu-NU101",[15],{"type":16,"name":9,"description":11,"armGroupLabels":17,"otherNames":18},"DRUG",[9],null,[20,25],{"name":21,"role":22,"phone":23,"phoneExt":18,"email":24},"Gary Ulaner, MD, PhD","CONTACT","949-557-0285","gary.ulaner@hoag.org",{"name":26,"role":22,"phone":23,"phoneExt":18,"email":27},"Beth Thomsen, CNMT","beth.thomsen@hoag.org",[29,47],{"facility":30,"status":18,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Hoag Family Cancer Institute","Newport Beach","California","92663","United States","US",{"type":37,"coordinates":38},"Point",[39,40],-117.92895,33.61891,{"lat":40,"lon":39},[43,45],{"name":44,"role":22,"phone":23,"phoneExt":18,"email":27},"Beth Thomsen, CNMT, CRC",{"name":21,"role":46,"phone":18,"phoneExt":18,"email":18},"PRINCIPAL_INVESTIGATOR",{"facility":48,"status":18,"city":49,"state":50,"zip":51,"country":34,"countryCode":35,"cosmosGeoPoint":52,"geoPoint":56,"contacts":57},"Washington Univeristy School of Medicine","St Louis","Missouri","63110",{"type":37,"coordinates":53},[54,55],-90.19789,38.62727,{"lat":55,"lon":54},[58],{"name":59,"role":22,"phone":18,"phoneExt":18,"email":18},"Vikas Prasad",{"type":46,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Gary Ulaner","James & Pamela Muzzy Endowed Chair of Molecular Imaging and Therapy",[64,66],{"name":65,"class":6},"Washington University School of Medicine",{"name":67,"class":68},"Nuclidium","UNKNOWN","100643370","phase-2-a-phase-2-trial-of-61cu-nu101-petct-compared-against-current-standard-of-care-18f-piflufolastat-pylarify-petct-100643370",false,"NCT07635524","A Phase 2 Trial of 61Cu-NU101 PET\u002FCT Compared Against Current Standard-of-care 18F-piflufolastat (Pylarify®) PET\u002FCT.","A Two Center Phase 2 Trial of 61Cu-noDAGa-PSMA I&T (61Cu-NU101) for Patients With Prostate Cancer","Inclusion Criteria:\n\n1. Biopsy proven prostate adenocarcinoma\n2. Age ≥ 18 years\n3. ECOG 0 or 2 4 .Oligometastatic disease (1-5 radiotracer avid disease sites) on 18F- piflufolastat PET\u002FCT within 30 days of trial recruitment\n\nExclusion Criteria:\n\n1. Known allergy\u002Fhypersensitivity to PSMA-targeted imaging agents\n2. Other active malignancy, other than the known prostate cancer","MALE","18 Years",{"count":79,"type":80},34,"ESTIMATED","INTERVENTIONAL",[83],"PHASE2","The purpose of this research is to test whether a new investigational Molecular Imaging (MI) agent called 61Cu-NU101 is equal to or better than a currently used MI agent, Pylarify, for the detection of prostate cancer metastases.\n\n34 participants with biopsy-proven prostate cancer and cancer seen on a Pylarify PET scan will be enrolled in this study.\n\nThe investigational 61Cu-NU101 PET\u002FCT will be perfromed. If there is a difference between the standard Pylarify exam and the investigational 61Cu-NU101 exam, a biopsy of one lesion that is different between the two exams may be performed.",[86],"Prostate Cancer",[88,89,90,91,92],"prostate","cancer","metastatic","radiotracer","metastases","NOT_YET_RECRUITING","2026-06-03",{"date":96,"type":97},"2026-06-09","ACTUAL",{"date":99,"type":80},"2026-08-01",{"date":101,"type":80},"2028-10-01",{"name":5,"class":6},2]