[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04857502":3,"trial-entities:NCT04857502":120,"trial-summary:NCT04857502":123},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":62,"secondary_outcomes":66,"sex":71,"minimum_age":72,"maximum_age":72,"healthy_volunteers":73,"eligibility_criteria":74,"std_ages":86,"locations":90,"central_contacts":113,"overall_officials":116,"references":118,"see_also_links":119},"NCT04857502","20-002256","99mTc-PSMA-I&S Biodistribution in Patients With Prostate Cancer","99mTc-PSMA-I&Amp;S in Patients With Prostate Cancer: An Exploratory Biodistribution Study With Histopathology Validation","RECRUITING","2028-06-01","2026-03","2026-07-17","2021-04-27","Jonsson Comprehensive Cancer Center","OTHER",true,"This exploratory study conducted under the RDRC program studies the biodistribution of 99mTc-PSMA-I\\&S in patients with prostate cancer who undergo pelvic lymph node dissection. Prostate specific membrane antigen (PSMA)-targeted radio-guided surgery uses the preoperative intravenous administration of a PSMA-ligand called PSMA-imaging and surgery (I\\&S) labeled with the gamma-emitter radioisotope Technetium-99m (99mTc). Giving 99mTc-PSMA-I\\&S may detect PSMA-expressing lymph nodes during surgery using a gamma probe and may help guide doctors to detect prostate cancer that has spread to the lymph nodes.","PRIMARY OBJECTIVE:\n\nI. To define the biodistribution of 99mTc-based PSMA imaging and surgery agent (99mTc-PSMA-I\\&S) in normal and malignant tissues of patients with prostate cancer (PCa) with histopathology validation, when available.\n\nSECONDARY OBJECTIVES:\n\nI. To correlate the 99mTc-PSMA-I\\&S accumulation within tumor lesions observed by in-vivo single-photon emission computed tomography (SPECT), ex-vivo gamma measurements and level of prostate-specific membrane antigen (PSMA) expression quantified by histopathology, when available.\n\nII. To define the best time-point for radio-guided surgery (RGS) with the highest tumor-to-background ratio following 99mTc-PSMA-I\\&S administration.\n\nOUTLINE:\n\nThe first 5 patients receive an initial dose of 99mTc-PSMA-I\\&S intravenously (IV) followed by 5 SPECT\u002FCT scans at 3-5, 5-20, 17-21, 25-29, and 40-46 hours later. These 5 patients then receive a second dose of 99mTc-PSMA-I\\&S IV and then undergo standard of care surgery. All subsequent patients receive one dose of 99mTc-PSMA-I\\&S IV before surgery.",[19,20],"Prostate Carcinoma","Recurrent Prostate Carcinoma",[],"INTERVENTIONAL","BASIC_SCIENCE",[25],"EARLY_PHASE1",{"count":27,"type":28},30,"ESTIMATED",[30,36,49],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DRUG","99mTc-based PSMA Imaging and Surgery Agent","Given via IV injection",[35],"Diagnostic (99mTc-PSMA-I&S, SPECT\u002FCT)",{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"PROCEDURE","Computed Tomography","Undergo SPECT\u002FCT",[35],[42,43,44,45,46,47,48],"CAT","CAT Scan","Computerized Axial Tomography","Computerized Tomography","CT","CT Scan","tomography",{"type":37,"name":50,"description":39,"armGroupLabels":51,"otherNames":52},"Single Photon Emission Computed Tomography",[35],[53,54,55,56,57,58,59,60,61],"Medical Imaging, Single Photon Emission Computed Tomography","Single Photon Emission Tomography","single-photon emission computed tomography","SPECT","SPECT imaging","SPECT SCAN","SPET","tomography, emission computed, single photon","Tomography, Emission-Computed, Single-Photon",[63],{"measure":64,"timeFrame":65},"The biodistribution of 99mTc-PSMA-I&S in normal and malignant tissues of patients with prostate cancer will be measured by average and maximum standardized uptake value (SUVmean and SUVmax)","time from injection to imaging (range: 1-46 hours)",[67,69],{"measure":68,"timeFrame":65},"99mTc-PSMA-I&S accumulation within tumor lesions observed by in-vivo SPECT (SUVmean and SUVmax) will be correlated with ex-vivo gamma measurements (counts\u002Fminute) and level of PSMA expression quantified by histopathology (IHC score)",{"measure":70,"timeFrame":65},"The best time-point for 99mTc-PSMA-I&S radioguided surgery will be determined by the tumor-to-background uptake ratio (TBR) using the time-activity curve function","MALE",null,false,{"inclusion":75,"exclusion":82,"raw_text":85},[76,77,78,79,80,81],"Men with PCa (primary or recurrent disease)","Men who received a 68Ga-PSMA-11 positron emission tomography (PET)\u002Fcomputed tomography (CT) for staging or restaging","Men with evidence of lymph nodes (LNs)-positive disease on 68Ga-PSMA-11 PET\u002FCT","Men who are scheduled for pelvic LN dissection (PLND)","Men who can provide oral and written informed consent","Men who can comply with study procedures",[83,84],"Patients who started any PCa treatment between study enrollment and surgery","Technically inaccessible nodal location","Inclusion Criteria:\n\n* Men with PCa (primary or recurrent disease)\n* Men who received a 68Ga-PSMA-11 positron emission tomography (PET)\u002Fcomputed tomography (CT) for staging or restaging\n* Men with evidence of lymph nodes (LNs)-positive disease on 68Ga-PSMA-11 PET\u002FCT\n* Men who are scheduled for pelvic LN dissection (PLND)\n* Men who can provide oral and written informed consent\n* Men who can comply with study procedures\n\nExclusion Criteria:\n\n* Patients who started any PCa treatment between study enrollment and surgery\n* Technically inaccessible nodal location",[87,88,89],"CHILD","ADULT","OLDER_ADULT",[91],{"facility":92,"status":8,"city":93,"state":94,"zip":95,"country":96,"contacts":97,"geoPoint":110},"UCLA \u002F Jonsson Comprehensive Cancer Center","Los Angeles","California","90095","United States",[98,103,107],{"name":99,"role":100,"phone":101,"email":102},"Deepu Varughese","CONTACT","310-206-7372","DVarughese@mednet.ucla.edu",{"name":104,"role":100,"phone":105,"email":106},"Ankush Sachdeva","310-794-3421","ASachdeva@mednet.ucla.edu",{"name":108,"role":109},"Jeremie Calais, MD","PRINCIPAL_INVESTIGATOR",{"lat":111,"lon":112},34.05223,-118.24368,[114,115],{"name":99,"role":100,"phone":101,"email":102},{"name":104,"role":100,"phone":105,"email":106},[117],{"name":108,"affiliation":92,"role":109},[],[],{"nct_id":4,"conditions":121,"biomarkers":122},[19],[],{"nct_id":4,"found":15,"summary":124,"prompt_version":134},{"design":125,"status":126,"heading":127,"summary":128,"follow_up":129,"word_count":130,"commitments":131,"compensation":132,"drugs_mentioned":133},"This is an interventional study with 30 participants. The first 5 participants will receive two doses of 99mTc-PSMA-I&S and undergo multiple SPECT\u002FCT scans, while subsequent participants receive one dose before surgery.","completed","Studying 99mTc-PSMA-I&S in Prostate Cancer","This study is looking at how a special imaging agent, 99mTc-PSMA-I&S, spreads throughout the body in men with prostate cancer. This agent is given through an IV and helps doctors see if prostate cancer has spread to the lymph nodes during surgery. You might be able to join if you are a man with prostate cancer (either new or returning), have had a 68Ga-PSMA-11 PET\u002FCT scan showing lymph nodes are involved, and are scheduled for lymph node removal surgery. The main goal is to understand how much of the 99mTc-PSMA-I&S is found in both healthy and cancerous tissues. The study is currently unclear on its recruitment status and plans to enroll 30 participants.","The primary endpoint measures are taken at various times from 1 to 46 hours after injection, which suggests imaging will occur within this timeframe.",113,"You would receive an IV injection of 99mTc-PSMA-I&S and undergo SPECT\u002FCT scans. If you are one of the first 5 participants, you will have 5 scans over 1-46 hours after the first dose, then a second dose before surgery.","Not stated in the trial record.",[],"v2"]