Solid Tumor
Conditions
Brief 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.
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
DRUG18F-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.
Sponsors
Hua Zhu
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Standardized Uptake Value (SUV) | Quantitative analysis was performed at all imaging time points within two weeks after the end of imaging. | Parameters of SUV The maximum standardized uptake value (SUVmax), mean standardized uptake value (SUVmean) and tumor/background ratio (SUVR) of \[68Ga\]Ga-THP-PDL1-3 in target lesions were observed. SUVR was calculated as the SUVmax of the target lesion divided by the SUVmean of the reference normal tissue. |
Countries
China
Contacts
CONTACTHua Zhu
PRINCIPAL_INVESTIGATORHua Zhu
Peking University Cancer Hospital & Institute
Outcome results
None listed