PD-L1 Specific [68Ga]Ga-THP-PDL1-3 Probe for PET Imaging in Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 18F-FDG, [68Ga]Ga-THP-PDL1-3.
- Who it may be relevant to
- Registry conditions: Solid Tumor. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A First-in-human, Non-randomised, Single-arm Pilot and Feasibility Study of [68Ga]Ga-THP-PDL1-3 PET/CT in Patients With Solid Tumors
Overview
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.
Detailed description
Analysis plan: 1. recruit 10 participants to analyze preliminary pharmacokinetic/first-in-human dose (FIH), major organ distribution and tumor uptake information via whole-body PET/CT imaging; 2. recruit 20-30 participants to analyze in vivo safety and tumor targeting information; and 3. recruit all participants for a final summary.
Interventions
- Drug 18F-FDG
All study participants will undergo one 18F-FDG PET/CT scan. - Drug [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.
Primary outcome measures
- Safety and Feasibility [Time frame: 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.]
Secondary outcome measures (1)
- Standardized Uptake Value (SUV) [Time frame: Quantitative analysis was performed at all imaging time points within two weeks after the end of imaging.]
Eligibility criteria
Inclusion criteria
- Age 18-70 years, ECOG score 0 or 1;
- Patients with solid tumors;
- Presence of measurable lesions on imaging examinations;
- Expected survival ≥12 weeks.
Exclusion criteria
- Severe hepatic or renal dysfunction;
- Women who are planning pregnancy, pregnant, or breastfeeding;
- Unable to remain in supine position for 30 minutes;
- Refusal to participate in this clinical study;
- Diagnosis of claustrophobia or other psychiatric disorders;
- Other conditions deemed by the investigator as inappropriate for participation in the trial.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
China · 1 center
- Beijing Cancer Hospital — Beijing
Identifiers
NCT: NCT06383598 · 2022KT74-ZY01