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

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

Recruiting
18 years and older
All
Phase 2

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Overview

\[18F\]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

Description

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.

Eligibility

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.

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

NCT07848243

Peking University Cancer Hospital & Institute

20 October 2026

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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