A Phase 2 interventional study of 18F-FDG and [18F]F-PDL1-3 in Lung Cancer (NSCLC), Cervical Squamous Cell Cancer and Melanoma (Skin Cancer), sponsored by Peking University Cancer Hospital & Institute. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Peking University Cancer Hospital & Institute · Phase 2, Interventional, and Diagnostic
[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/or recurrence or metastasis, and ultimately achieve individualized targeted therapy of tumors
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/CT examination.
Exclusion Criteria:
All study participants will be assigned to this group (single-group study). Study participants will undergo \[18F\]F-PDL1-3 PET/CT scans. The injection dose was 1.52-2.72 MBq/kg. Whole-body imaging of the head and trunk will be performed using a United imaging EXPLORER whole-body PET/CT 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/CT static imaging was performed at 3h after injection.
Drug: 18F-FDG · Drug: [18F]F-PDL1-3
participants were required to fast for more than 6 hours before examination. The prepared and qualified 18F-FDG 3.7-5.55MBq/kg was injected intravenously into the subjects. After 1 hour of rest, the subjects underwent Whole Body imaging with uEXPLORER whole-body PET/CT from the top of the head to the upper 1/3 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/CT fusion images
participants received intravenous \[18F\]F-PDL1-3 at a quality-control dose (1.52-2.72 MBq/kg). Whole-body imaging of the head and trunk will be performed using the United imaging uEXPLORER whole-body PET/CT 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/CT 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/CT fusion images.
Safety - Tracer-related Adverse Events
Number of participants with tracer-related adverse events.
Time frame: From the start of radiotracer administration through 7 days after injection.
Feasibility of PET/CT Imaging
Number of participants in whom evaluable PET/CT 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.
Time frame: Dynamic PET/CT scanning from 0 to 40 minutes post-injection; static PET/CT scans at 1 hour, 2 hours, and 3 hours post-injection.
Radiochemical Purity
Radiochemical purity of the radiotracer, reported as percentage (%), determined by iTLC. Criterion: ≥95%.
Time frame: 1 h before each injection on each imaging day
Bacterial Endotoxins
Bacterial endotoxin level, reported in EU/mL, determined by photometry. Criterion: ≤15 EU/mL.
Time frame: Before preparation of each drug batch.Once a month.
Standardized Uptake Value (SUV)
Parameters of SUV The maximum standardized uptake value (SUVmax), mean standardized uptake value (SUVmean) and tumor/background 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
Time frame: Quantitative analysis was performed at all imaging time points within two weeks after the end of imaging.
Plan to share: Yes — In accordance with the ICMJE data-sharing guidelines and Chinese data-privacy laws, raw clinical and imaging data were not publicly available to prevent compromise of patient privacy. However, the corresponding author will share deidentified patient-level data, imaging parameters (SUV values), and study protocol details if reasonable requested by the requestor.
Supporting information: Study protocol, Sap, Icf
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Peking University Cancer Hospital & Institute