Patients with malignant tumors requiring immunotherapy
Conditions
Interventions
Gold Standard:The currently commonly used detection method for PD-L1 is immunohistochemistry (IHC). Methods such as Tumor Proportion Score (TPS), immune cells (IC) positive score, and Combined Positiv
Index test:18F-PDL1 PET/CT imaging
Sponsors
Peking University Shenzhen Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. All subjects had their PD-L1 protein expression status detected by immunohistochemical staining (IHC) of pathological sections before imaging, either due to clinical treatment needs or patient requirements. 2. The subjects voluntarily participate in this trial and sign the informed consent form. 3. Aged >= 18 years and <= 80 years (based on the date of signing the informed consent form), with no restriction on gender. 4. Patients with a clear diagnosis of malignant tumors. 5. Physical fitness status score: 0~1 point. 6. Expected survival time of more than 12 months. 7. Female subjects of childbearing age, male subjects, and the partners of male subjects agree to use reliable contraceptive methods (such as abstinence, sterilization surgery, contraceptives, injectable contraceptive medroxyprogesterone, or subcutaneous implant contraception, etc.) within 6 months after the end of the last study drug infusion. 8. Be willing and able to comply with scheduled visits, diagnostic plans, clinical laboratory tests, and other trial procedures.
Exclusion criteria
Exclusion criteria: 1. Previously used radionuclides, and the interval from the administration in this study is less than 10 physical half-lives. 2. Currently participating in or planning to participate in any drug or device clinical trial during the study period. 3. Unable to lie flat or remain still during a PET scan, or intolerant of PET scans. 4. Those with a history of fracture or anemia in the past year. 5. Subjects with abnormalities in physical examination, ECG, and clinical laboratory tests during the screening period, which, as determined by the investigator, may affect safety or compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum standardized uptake value;AUC of the new imaging agent; | — |
Countries
China
Contacts
Public ContactDong Mengjie
Peking University Shenzhen Hospital
Outcome results
None listed