PD-L1-targeted PET probe to map PD-L1 in solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional study uses an 18F-labeled PD-L1 probe to image PD-L1 expression in patients with solid tumors, including NSCLC, cervical cancer, melanoma, breast cancer, and gastrointestinal cancers. Participants undergo dynamic and static PET/CT imaging after administration of the tracer, with follow-up medical record collection to compare imaging results with tissue PD-L1 status and monitor changes over time. The trial aims to assess whether the imaging results correlate with traditional biopsy findings and whether they can support patient selection, treatment monitoring, and early detection of resistance or progression. Enrollment targets 50 patients, with standardized imaging protocols and data collection across time points. Safety and feasibility of the imaging approach are also evaluated.

Why it matters

Who can join: the full rules

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.

Where it's running

• Beijing Cancer hospital
  Beijing, China Recruiting

Study contacts

• Principal investigator: Hua Zhu — Peking University Cancer Hospital & Institute
• Study coordinator: Hua Zhu
• Email: zhuhuabch@pku.edu.cn
• Phone: 010-88196495

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.