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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [68Ga]Ga-THP-PDL1-3 | Experimental | All study participants will be allocated to this arm (single-arm study).Study participants will undergo [68Ga]Ga-THP-PDL1-3 PET/CT scans.After the participant rests quietly for 40 minutes or 1 hour, whole-body imaging of the head and torso will be performed using a United Imaging uEXPLORER Whole-Body PET/CT scanner at 1 h, 2 h, and 3 h post-injection. The scan range will cover from the vertex to the upper third of the thighs. Participants who required a dynamic scan underwent a 40-min serial scan after injection of [68Ga]Ga-THP-PDL1-3. PET/CT static imaging was performed at 2 h and 3 h after injection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-FDG | Drug | All study participants will undergo one 18F-FDG PET/CT scan. |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety and Feasibility |
Safety and feasibility were evaluated by no adverse events after comprehensive indicators. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Standardized Uptake Value (SUV) | 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. | Quantitative analysis was performed at all imaging time points within two weeks after the end of imaging. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hua Zhu | Contact | 010-88196495 | zhuhuabch@pku.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Hua Zhu | Peking University Cancer Hospital & Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
In accordance with the ICMJE data-sharing guidelines and Chinese data-privacy laws, raw clinical and imaging data were not publicly available to prevent compromise of patient privacy. However, the corresponding author will share deidentified patient-level data, imaging parameters (SUV values), and study protocol details if reasonably requested by the requestor.
Data access will be granted through a secure data sharing agreement for a period of 3 years after publication.
Applicants must provide a methodologically sound research plan and obtain approval from their institutional ethics committee.
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| ID | Term |
|---|---|
| D019788 | Fluorodeoxyglucose F18 |
| ID | Term |
|---|---|
| D003847 | Deoxyglucose |
| D003837 | Deoxy Sugars |
| D002241 | Carbohydrates |
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| [68Ga]Ga-THP-PDL1-3 |
| Drug |
[68Ga]Ga-THP-PDL1-3 is an investigational tracer, and all participants will undergo [68Ga]Ga-THP-PDL1-3 scanning. |
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