[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572652":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":19,"locations":20,"responsibleParty":43,"collaborators":19,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":19,"eligibilityCriteria":50,"healthyVolunteers":47,"sex":51,"minAge":52,"maxAge":19,"enrollmentInfo":53,"targetDuration":19,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":22,"whyStopped":19,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},{"fullName":5,"class":6},"Hoag Memorial Hospital Presbyterian","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Prostate Adenocarcinoma with PSMA-Positive Disease on a PSMA Targeted PET\u002FCT","EXPERIMENTAL","TEST PRODUCT, DOSE, AND ROUTE OF ADMINISTRATION: Subjects will undergo imaging with 100-300 MBq (2.7-8.1 mCi) of 61Cu-NODAGA-PSMA intravenously (IV), followed by PET\u002FCT imaging 60 (+\u002F- 10) minutes post radiotracer administration.",[13],"Drug: Copper 61-PSMA PET\u002FCT",[15],{"type":16,"name":17,"description":11,"armGroupLabels":18,"otherNames":19},"DRUG","Copper 61-PSMA PET\u002FCT",[9],null,[21],{"facility":5,"status":22,"city":23,"state":24,"zip":25,"country":26,"countryCode":27,"cosmosGeoPoint":28,"geoPoint":33,"contacts":34},"RECRUITING","Irvine","California","92616","United States","US",{"type":29,"coordinates":30},"Point",[31,32],-117.82311,33.66946,{"lat":32,"lon":31},[35,40],{"name":36,"role":37,"phone":38,"phoneExt":19,"email":39},"Gary A Ulaner, MD, PhD","CONTACT","949-557-0285","gary.ulaner@hoag.org",{"name":41,"role":37,"phone":38,"phoneExt":19,"email":42},"Beth Thomsen, CNMT","beth.thomsen@hoag.org",{"type":44,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100572652","phase-1-a-phase-i-trial-of-61cu-nodaga-psma-for-patients-with-prostate-cancer-100572652",false,"NCT06736054","A Phase I Trial of 61Cu-NODAGA-PSMA for Patients with Prostate Cancer","Inclusion Criteria:\n\n1. Biopsy proven prostate adenocarcinoma\n2. Age ≥ 18 years\n3. ECOG 0 or 1\n4. At least one site of PSMA-positive disease on a PSMA-targeted PET\u002FCT performed within 30 days of trial recruitment\n5. Creatinine of ≤1.4 or Creatinine Clearance or ≥ 60 mL\u002Fminute.\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":54,"type":55},8,"ESTIMATED","INTERVENTIONAL",[58],"PHASE1","Molecular Imaging (MI) uses tracers which emit radiation to provide clinically valuable imaging for patient with cancer. Most current MI agents utilize Fluorine 18 or Gallium 68 as the positron emitter for PET imaging. However, these isotopes have short half-lives which limit the geographic distribution range of tracers made with these isotopes. Copper 61 (61Cu) has a 3.3 hour half-life, which would allow for far greater distribution range following radiotracer production.\n\nThis phase I trial will test the safety and effectiveness of a novel MI radiotracer that uses 61Cu as its positron emitting isotope and targets Prostate Specific Membrane Antigen (PSMA) for imaging prostate cancer. A successful trial will provide the ability to advance this novel 61Cu-NODAGA-PSMA radioisotope into phase II trials, as well as open a new paradigm into the production of MI radioisotopes with 61Cu.",[61],"Prostate Adenocarcinoma",[63,64,65],"PSMA","PET\u002FCT","Phase 1","2024-12-12",{"date":68,"type":69},"2024-12-16","ACTUAL",{"date":71,"type":69},"2024-10-14",{"date":73,"type":55},"2025-03-31",{"name":5,"class":6},1]