Clinical Investigator-Initiated Trial (IIT) of PD-L1-Targeted Radionuclide Probes

Condition(s) studied

Investigational drug(s) / intervention(s)

18F-FDG: 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

[18F]F-PDL1-3: 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.

Study summary

\[18F\]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

Eligibility

Primary outcome measure(s)

• Safety - Tracer-related Adverse Events — From the start of radiotracer administration through 7 days after injection.
  Number of participants with tracer-related adverse events.
• Feasibility of PET/CT Imaging — 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.
  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.
• Radiochemical Purity — 1 h before each injection on each imaging day
  Radiochemical purity of the radiotracer, reported as percentage (%), determined by iTLC. Criterion: ≥95%.
• Bacterial Endotoxins — Before preparation of each drug batch.Once a month.
  Bacterial endotoxin level, reported in EU/mL, determined by photometry. Criterion: ≤15 EU/mL.

Trial sites (1)

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