18F-FDG: All study participants will undergo one 18F-FDG PET/CT scan.
[68Ga]Ga-THP-PDL1-3: \[68Ga\]Ga-THP-PDL1-3 is an investigational tracer, and all participants will undergo \[68Ga\]Ga-THP-PDL1-3 scanning.
Study summary
To utilize the \[68Ga\]Ga-THP-PDL1-3 molecular probe to non-invasively detect PD-L1 expression in primary and metastatic lesions of patients with solid tumors. Furthermore, to assess the heterogeneity of PD-L1 expression within the same lesion and across different lesions, and to observe changes in PD-L1 expression during the course of treatment. This approach aims to facilitate patient screening, therapeutic monitoring, and early warning of drug resistance and/or recurrence or metastasis in the treatment of solid tumors with high PD-L1 expression, ultimately enabling personalized targeted therapy in oncology.
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria:
1. Age 18-70 years, ECOG score 0 or 1;
2. Patients with solid tumors;
3. Presence of measurable lesions on imaging examinations;
4. Expected survival ≥12 weeks.
Exclusion Criteria:
1. Severe hepatic or renal dysfunction;
2. Women who are planning pregnancy, pregnant, or breastfeeding;
3. Unable to remain in supine position for 30 minutes;
4. Refusal to participate in this clinical study;
5. Diagnosis of claustrophobia or other psychiatric disorders;
6. Other conditions deemed by the investigator as inappropriate for participation in the trial.
Primary outcome measure(s)
Safety and Feasibility — 1. From the start of drug administration to 14 days after injection 2.Dynamic PET/CT scanning from 0 to 40 minutes post-injection, followed by static scans at 1 hour, 2 hours, and 3 hours post-injection. 3.Prior to each patient injection. 1. Adverse Event Number of participants with tracer-related adverse events.
2. Feasibility of PET/CT Imaging Number of participants in whom evaluable PET/CT images were successfully acquired at prespecified time points, as independently assessed by a senior nuclear medicine physician. Images were considered evaluable if they met diagnostic quality criteria.
3. Quality Control Standards for the Radiotracer Radiochemical purity ≥95% (determined by iTLC); Sterility (tested by the direct inoculation method according to pharmacopoeial standards); Bacterial endotoxins ≤15 EU/mL (as determined by photometry).
4. Radiation Dosimetry Organ-absorbed doses (mGy/MBq) and effective dose (mSv/MBq) calculated from PET/CT data using OLINDA/EXM software based on the MIRD schema. Organs assessed include, but are not limited to, the liver, spleen, kidneys, lungs, heart, bone marrow, and urinary bladder.
Safety and feasibility were evaluated by no adverse events after comprehensive indicators.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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