RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Peking University Cancer Hospital & Institute • ClinicalTrials.gov ID: NCT07848243

Registry updated: 2026-09-29

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

\[18F\]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

Interventions

18F-FDG (Drug)
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 (Drug)
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.

Eligibility criteria

Inclusion Criteria: 1. Age \>18 years old, ECOG score 0 or 1; 2. 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; 3. There was at least one measurable target lesion according to RECIST1.1 criteria; 4. Predicted survival time ≥12 weeks; 5. Blood routine, liver and kidney function meet the following standards: see the study protocol for specific requirements; 6. Women must be using an effective contraceptive method (effective contraception means sterilization, intrauterine hormonal devices, condoms, contraceptives/pills, 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; 7. Subjects can fully understand and voluntarily participate in this experiment, and sign an informed consent. Compliance was good. Exclusion Criteria: 1. Severe abnormal liver and kidney function. 2. Pre-pregnancy, pregnant and lactating women. 3. Unable to lie flat for half an hour. 4. Refusal to be a clinical investigator. 5. Claustrophobia or other mental illness. 6. 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.

Conditions

Lung Cancer (NSCLC) Cervical Squamous Cell Cancer Melanoma (Skin Cancer) Breast Cancer Gastrointestinal Cancers

Locations

Beijing Cancer hospital — Beijing, China

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment