[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05160480":3,"trial-entities:NCT05160480":76,"trial-summary:NCT05160480":83},{"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":21,"study_type":22,"primary_purpose":16,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":34,"secondary_outcomes":39,"sex":40,"minimum_age":41,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":42,"std_ages":56,"locations":59,"central_contacts":69,"overall_officials":70,"references":74,"see_also_links":75},"NCT05160480","1837303","A Pilot Study of Total-body PET Using FDA-approved Radiotracers Beyond 18F-FDG","ENROLLING_BY_INVITATION","2026-09-01","2026-01","2026-03-10","2024-06-07","University of California, Davis","OTHER",false,"The purpose of this research study is to test new ways to improve the usefulness of the world's first total-body positron emission tomography (PET)\u002Fcomputed tomography (CT) scanner (EXPLORER) by collecting data from PET scans using one of three different imaging agents: 18F-PSMA; 18F-FES; or, 68Ga DOTATATE. These imaging agents are approved by the FDA to be used for patients diagnosed with prostate cancer (18F-PSMA), neuroendocrine tumor (68Ga DOTATATE), or breast cancer (18F-FES).",null,[18,19,20],"Prostate Cancer","Breast Cancer","Neuroendocrine Tumors",[],"OBSERVATIONAL",[],{"count":25,"type":26},9,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DIAGNOSTIC_TEST","Total-body PET imaging","Total-body PET imaging at different timepoints",[33],"Total-body PET scan",[35],{"measure":36,"description":37,"timeFrame":38},"measure radiotracer avidity","measure radiotracer avidity, i.e. standardized uptake value measurements (SUV max and mean) of tumor and normal tissue as a function of time with 18F-PSMA, 18F-FES, 68Ga DOTATATE in a total-body PET scanner among men with suspected prostate cancer metastasis, patients suspicious for or diagnosed with somatostatin receptor positive neuroendocrine tumors, and patients with recurrent or metastatic breast cancer.","One study imaging visit lasting up to 10 hours",[],"ALL","18 Years",{"inclusion":43,"exclusion":48,"raw_text":55},[44,45,46,47],"Persons \\>18 yo with suspected prostate cancer metastasis","Prior imaging study (CT, and\u002For MRI and\u002For Bone scan and\u002For Fluciclovine scan) suspicious for metastatic disease, obtained within 4 months from the research scan date.","Persons \\> 18 yo suspicious for or diagnosed with somatostatin receptor positive neuroendocrine tumors (NETs)","Prior DOTATATE PET\u002FCT scan suspicious for tumor obtained not earlier than 4 months from the research scan date.",[49,50,51,52,53,54],"Adults unable to consent","Pregnant\u002Flactating persons","Prisoners","Unable to lie supine for up to 90 minutes at different timepoints in the PET scanner","Uncontrolled claustrophobia","Any significant medical condition that in the opinion of the investigator would prevent the participant from participating and\u002For adhering to study related procedures or interfere with participant safety","18F-PSMA (n=3) and 68Ga-PSMA (n=3)\n\nInclusion criteria:\n\n* Persons \\>18 yo with suspected prostate cancer metastasis\n* Prior imaging study (CT, and\u002For MRI and\u002For Bone scan and\u002For Fluciclovine scan) suspicious for metastatic disease, obtained within 4 months from the research scan date.\n\n  68Ga DOTATATE (n=3) or 64Cu-DOTATATE (n=3)\n\nInclusion Criteria:\n\n* Persons \\> 18 yo suspicious for or diagnosed with somatostatin receptor positive neuroendocrine tumors (NETs)\n* Prior DOTATATE PET\u002FCT scan suspicious for tumor obtained not earlier than 4 months from the research scan date.\n\nExclusion Criteria:\n\n• Recent administration of long-acting somatostatin analogs\n\nExclusion Criteria for all participants:\n\n* Adults unable to consent\n* Pregnant\u002Flactating persons\n* Prisoners\n* Unable to lie supine for up to 90 minutes at different timepoints in the PET scanner\n* Uncontrolled claustrophobia\n* Any significant medical condition that in the opinion of the investigator would prevent the participant from participating and\u002For adhering to study related procedures or interfere with participant safety",[57,58],"ADULT","OLDER_ADULT",[60],{"facility":61,"city":62,"state":63,"zip":64,"country":65,"geoPoint":66},"UC Davis EXPLORER Molecular Imaging Center","Sacramento","California","95816","United States",{"lat":67,"lon":68},38.58157,-121.4944,[],[71],{"name":72,"affiliation":12,"role":73},"Lorenzo Nardo, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":77,"biomarkers":80},[78,79],"Neuroendocrine Neoplasm","Prostate Carcinoma",[81,82],"FOLH1 Gene","Somatostatin Receptor",{"nct_id":4,"found":14,"summary":16,"prompt_version":16}]