[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658072":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":37,"studyPopulation":30,"armGroups":38,"interventions":46,"overallOfficials":55,"centralContacts":59,"locations":64,"responsibleParty":79,"collaborators":30,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":85,"acronym":30,"eligibilityCriteria":86,"healthyVolunteers":83,"sex":87,"minAge":88,"maxAge":30,"enrollmentInfo":89,"targetDuration":30,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":102,"overallStatus":67,"whyStopped":30,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Peking University Cancer Hospital & Institute","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":25,"otherOutcomes":30},[9,13,17,21],{"measure":10,"description":11,"timeFrame":12},"Safety - Tracer-related Adverse Events","Number of participants with tracer-related adverse events.","From the start of radiotracer administration through 7 days after injection.",{"measure":14,"description":15,"timeFrame":16},"Feasibility of PET\u002FCT Imaging","Number of participants in whom evaluable PET\u002FCT images were successfully acquired at prespecified time points, as independently assessed by two senior nuclear medicine physicians. Images were considered evaluable if they met diagnostic quality criteria.","Dynamic PET\u002FCT scanning from 0 to 40 minutes post-injection; static PET\u002FCT scans at 1 hour, 2 hours, and 3 hours post-injection.",{"measure":18,"description":19,"timeFrame":20},"Radiochemical Purity","Radiochemical purity of the radiotracer, reported as percentage (%), determined by iTLC. Criterion: ≥95%.","1 h before each injection on each imaging day",{"measure":22,"description":23,"timeFrame":24},"Bacterial Endotoxins","Bacterial endotoxin level, reported in EU\u002FmL, determined by photometry. Criterion: ≤15 EU\u002FmL.","Before preparation of each drug batch.Once a month.",[26],{"measure":27,"description":28,"timeFrame":29},"Standardized Uptake Value (SUV)","Parameters of SUV The maximum standardized uptake value (SUVmax), mean standardized uptake value (SUVmean) and tumor\u002Fbackground ratio (SUVR) of \\[68Ga\\]Ga-THP-PDL1-3 in target lesions were observed. SUVR was calculated as the SUVmax of the target lesion divided by the SUVmean of the reference normal tissue","Quantitative analysis was performed at all imaging time points within two weeks after the end of imaging.",null,{"allocation":32,"interventionModel":33,"interventionModelDescription":30,"primaryPurpose":34,"observationalModel":30,"timePerspective":30,"maskingInfo":35},"NA","SINGLE_GROUP","DIAGNOSTIC",{"masking":36,"maskingDescription":30,"whoMasked":30},"NONE","According to the inclusion and exclusion criteria, 50 patients with solid tumors were selected. The first 5 subjects completed 45 minutes dynamic scan image acquisition, and then static scan was performed at subsequent time points. Each subject completed at least 1 hour and 2 hours of static acquisition, and 3 hours of image acquisition depending on the subject's physical condition and other comprehensive factors). Within 3 months after the subjects completed the examination, the researchers will retrieve the subjects' electronic medical records through the medical record system or telephone interview. The laboratory examination results, pathological results, and other imaging comprehensive diagnosis results of the subjects were collected, and the changes of lesions were observed. The expression level of PD-L1 in traditional tissue biopsy was compared with the results of \\[18F\\]F-PDL1-3 PET\u002FCT examination.",[39],{"label":40,"type":41,"description":42,"interventionNames":43},"[18F]F-PDL1-3","EXPERIMENTAL","All study participants will be assigned to this group (single-group study). Study participants will undergo \\[18F\\]F-PDL1-3 PET\u002FCT scans. The injection dose was 1.52-2.72 MBq\u002Fkg. Whole-body imaging of the head and trunk will be performed using a United imaging EXPLORER whole-body PET\u002FCT scanner at 1 h, 2 h, and 3 h post-injection after participants have rested quietly for 40 min or 1 h. The scan range was from the apex of the thigh to the upper third of the thigh. Participants requiring dynamic scanning underwent a 40-min serial scan after injection of \\[18F\\]F-PDL1-3.. PET\u002FCT static imaging was performed at 3h after injection.",[44,45],"Drug: 18F-FDG","Drug: [18F]F-PDL1-3",[47,52],{"type":48,"name":49,"description":50,"armGroupLabels":51,"otherNames":30},"DRUG","18F-FDG","participants were required to fast for more than 6 hours before examination. The prepared and qualified 18F-FDG 3.7-5.55MBq\u002Fkg was injected intravenously into the subjects. After 1 hour of rest, the subjects underwent Whole Body imaging with uEXPLORER whole-body PET\u002FCT from the top of the head to the upper 1\u002F3 of the thigh. Subjects were placed in the supine position and breathed calmly. The collection conditions of head and trunk were the same as above. The data were reconstructed by OSEM to obtain coronal, sagittal, and cross-sectional PET and PET\u002FCT fusion images",[40],{"type":48,"name":40,"description":53,"armGroupLabels":54,"otherNames":30},"participants received intravenous \\[18F\\]F-PDL1-3 at a quality-control dose (1.52-2.72 MBq\u002Fkg). Whole-body imaging of the head and trunk will be performed using the United imaging uEXPLORER whole-body PET\u002FCT scanner at 1 h, 2 h, and 3 h post-injection after the subject has rested quietly for 1 h. The scan range was from the apex of the thigh to the upper third of the thigh. Subjects requiring dynamic scanning underwent a 5-min CT scan prior to \\[18F\\]F-PDL1-3 injection, followed by 40 min of continuous image acquisition after injection. PET\u002FCT static imaging was performed at 2 h and 3 h after injection. During the scan, the subject will be placed in the supine position and breathe quietly. Acquisition parameters for the head and trunk will be as described above. The data were reconstructed using the OSEM algorithm to generate coronal, sagittal, and transverse axial PET and PET\u002FCT fusion images.",[40],[56],{"name":57,"affiliation":5,"role":58},"Hua Zhu","PRINCIPAL_INVESTIGATOR",[60],{"name":57,"role":61,"phone":62,"phoneExt":30,"email":63},"CONTACT","010-88196495","zhuhuabch@pku.edu.cn",[65],{"facility":66,"status":67,"city":68,"state":30,"zip":30,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"Beijing Cancer hospital","RECRUITING","Beijing","China","CN",{"type":72,"coordinates":73},"Point",[74,75],116.39723,39.9075,{"lat":75,"lon":74},[78],{"name":57,"role":61,"phone":62,"phoneExt":30,"email":63},{"type":58,"investigatorFullName":57,"investigatorTitle":80,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Associate Professor","100658072","phase-2-clinical-investigator-initiated-trial-iit-of-pd-l1-targeted-radionuclide-probes-100658072",false,"NCT07848243","Clinical Investigator-Initiated Trial (IIT) of PD-L1-Targeted Radionuclide Probes","Inclusion Criteria:\n\n1. Age \\>18 years old, ECOG score 0 or 1;\n2. subjects with pathologically confirmed solid tumors (lung cancer, cervical cancer, melanoma, breast cancer, gastrointestinal tumor, etc.), recent recurrence or suspected recurrence of previous solid tumors;\n3. There was at least one measurable target lesion according to RECIST1.1 criteria;\n4. Predicted survival time ≥12 weeks;\n5. Blood routine, liver and kidney function meet the following standards: see the study protocol for specific requirements;\n6. Women must be using an effective contraceptive method (effective contraception means sterilization, intrauterine hormonal devices, condoms, contraceptives\u002Fpills, abstinence, or partner's removal of the vas deferentia) during the study and for 6 months after the study; Men should consent to subjects who must use contraception during the study period and for 6 months after the end of the study period;\n7. Subjects can fully understand and voluntarily participate in this experiment, and sign an informed consent. Compliance was good.\n\nExclusion Criteria:\n\n1. Severe abnormal liver and kidney function.\n2. Pre-pregnancy, pregnant and lactating women.\n3. Unable to lie flat for half an hour.\n4. Refusal to be a clinical investigator.\n5. Claustrophobia or other mental illness.\n6. Known allergy to the investigational drug or its excipients in the study treatment; Other circumstances considered by the investigator to be inappropriate for trial participation.","ALL","18 Years",{"count":90,"type":91},50,"ESTIMATED","INTERVENTIONAL",[94],"PHASE2","\\[18F\\]F-PDL1-3 molecular probe was used to detect the expression of PD-L1 in primary and metastatic tumors of patients with solid tumors. The heterogeneity of PD-L1 expression in the same lesion and different lesions was further evaluated, and the changes of PD-L1 expression in the course of the disease were observed. This method is helpful for the screening of patients with solid tumors with high PD-L1 expression, efficacy monitoring, and early warning of drug resistance and\u002For recurrence or metastasis, and ultimately achieve individualized targeted therapy of tumors",[97,98,99,100,101],"Lung Cancer (NSCLC)","Cervical Squamous Cell Cancer","Melanoma (Skin Cancer)","Breast Cancer","Gastrointestinal Cancers",[103,104],"Radioactive medicine","De novo design","2026-09-23",{"date":107,"type":108},"2026-09-29","ACTUAL",{"date":110,"type":108},"2026-02-01",{"date":112,"type":91},"2027-12-31",{"name":5,"class":6},1]