[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06736054":3,"trial-entities:NCT06736054":89,"trial-summary:NCT06736054":94},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":37,"secondary_outcomes":42,"sex":49,"minimum_age":50,"maximum_age":51,"healthy_volunteers":14,"eligibility_criteria":52,"std_ages":56,"locations":59,"central_contacts":77,"overall_officials":78,"references":79,"see_also_links":88},"NCT06736054","189-21-CA","A Phase I Trial of 61Cu-NODAGA-PSMA for Patients with Prostate Cancer","RECRUITING","2025-03-31","2024-10","2024-12-16","2024-10-14","Hoag Memorial Hospital Presbyterian","OTHER",false,"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.","This is a phase 1, non-randomized study. 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. This is a diagnostic imaging study. As the imaging agent will not have a treatment effect, efficacy evaluations that are standard in treatment protocols will not be performed. We expect to enroll 6-10 patients in the proposed study. The sample size is exploratory.\n\nFor the primary objective of safety, side effects will be monitored the day of and the day following radiotracer administration. As the PET radiotracer used in this trial is given at a low, imaging dose, serious adverse events are not expected. If a single serious adverse event is identified, then the protocol will be held until reviewed by the IRB.\n\nFor the secondary objective of dosimetry, dosimetry will be calculated from PET\u002FCT images and radioactive counts in blood samples by an experience medical physicist.\n\nFor the secondary objective of effectiveness, the number of suspected PSMA-positive malignant lesions will be calculated in both the standard-of-care 18F-Piflufolastat PET\u002FCT and the experimental 61Cu- PSMA PET\u002FCT. Positive lesions will be considered to be the foci greater than local background that are not physiologic\u002Fbenign by location. The percentage of patients with any suspected PSMApositive malignant lesions will be determined for each radiotracer.",[18],"Prostate Adenocarcinoma",[20,21,22],"PSMA","PET\u002FCT","Phase 1","INTERVENTIONAL","DIAGNOSTIC",[26],"PHASE1",{"count":28,"type":29},8,"ESTIMATED",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DRUG","Copper 61-PSMA PET\u002FCT","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.",[36],"Prostate Adenocarcinoma with PSMA-Positive Disease on a PSMA Targeted PET\u002FCT",[38],{"measure":39,"description":40,"timeFrame":41},"Incidence of Imaging Agent-Emergent Adverse Events [Safety and Tolerability]","For the primary objective of safety, side effects will be monitored the day of and the day following radiotracer administration.","Up to 24 hours after administration of radiotracer",[43,46],{"measure":44,"description":45,"timeFrame":41},"Dosimetry","For the secondary objective of dosimetry, dosimetry will be calculated from PET\u002FCT images and radioactive counts in blood samples by an experience medical physicist.",{"measure":47,"description":48,"timeFrame":41},"Number of suspected PSMA-positive malignant lesions","For the secondary objective of effectiveness, the number of suspected PSMA-positive malignant lesions will be calculated in both the standard-of-care 18F-Piflufolastat PET\u002FCT and the experimental 61Cu-PSMA PET\u002FCT. Positive lesions will be considered to be the foci greater than local background that are not physiologic\u002Fbenign by location. The percentage of patients with any suspected PSMA-positive malignant lesions will be determined for each radiotracer.","MALE","18 Years",null,{"inclusion":53,"exclusion":54,"raw_text":55},[],[],"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",[57,58],"ADULT","OLDER_ADULT",[60],{"facility":12,"status":7,"city":61,"state":62,"zip":63,"country":64,"contacts":65,"geoPoint":74},"Irvine","California","92616","United States",[66,71],{"name":67,"role":68,"phone":69,"email":70},"Gary A Ulaner, MD, PhD","CONTACT","949-557-0285","gary.ulaner@hoag.org",{"name":72,"role":68,"phone":69,"email":73},"Beth Thomsen, CNMT","beth.thomsen@hoag.org",{"lat":75,"lon":76},33.66946,-117.82311,[],[],[80,84],{"pmid":81,"type":82,"citation":83},"39025646","BACKGROUND","Basaco Bernabeu T, Mansi R, Del Pozzo L, Zanger S, Gaonkar RH, McDougall L, De Rose F, Jaafar-Thiel L, Herz M, Eiber M, Ulaner GA, Weber WA, Fani M. 61Cu-PSMA-Targeted PET for Prostate Cancer: From Radiotracer Development to First-in-Human Imaging. J Nucl Med. 2024 Sep 3;65(9):1427-1434. doi: 10.2967\u002Fjnumed.123.267126.",{"pmid":85,"type":86,"citation":87},"41363974","DERIVED","Ulaner GA, Bassett JC, Reddy R, Thomsen B, Reynolds D, Jerjian KJ, Wolfe R, Benjamin DJ, Fani M, O'Donoghue J, Baier M, Schubert N, Pais B, De Rose F, Jaafar L. 61Cu-NODAGA Prostate-specific Membrane Antigen Imaging and Therapy for Prostate Cancer: Phase 1 Trial of a New Class of 61Cu-labeled PET Radiotracers. Radiology. 2025 Dec;317(3):e251151. doi: 10.1148\u002Fradiol.251151.",[],{"nct_id":4,"conditions":90,"biomarkers":92},[91],"Prostate Carcinoma",[93],"FOLH1 Gene",{"nct_id":4,"found":95,"summary":96,"prompt_version":106},true,{"design":97,"status":98,"heading":99,"summary":100,"follow_up":101,"word_count":102,"commitments":103,"compensation":104,"drugs_mentioned":105},"This is a Phase 1 study, meaning it's an early-stage trial to check safety. It is not randomized and plans to enroll 6-10 participants.","completed","Phase 1 Trial of 61Cu-NODAGA-PSMA for Prostate Cancer","This study is testing a new way to image prostate cancer using a special tracer called 61Cu-NODAGA-PSMA. This tracer helps doctors see prostate cancer cells better on a PET\u002FCT scan. The main goal is to check if 61Cu-NODAGA-PSMA is safe and doesn't cause too many side effects. Researchers will also look at how well it images prostate cancer compared to standard imaging. You might be able to join if you are a man, 18 or older, have prostate cancer confirmed by a biopsy, and have prostate cancer that shows up on a PSMA-targeted PET\u002FCT scan. The study is currently enrolling a small number of participants.","Your safety will be monitored for up to 24 hours after receiving the radiotracer.",105,"You would receive an intravenous (IV) injection of 61Cu-NODAGA-PSMA, followed by a PET\u002FCT scan about an hour later. Side effects will be monitored for up to 24 hours after the injection.","Not stated in the trial record.",[],"v2"]