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Evaluation of [18F]AlF-NOTA-PCP2 PET/CT for PD-L1 Detection in Malignant Tumors
Sponsor: Man Hu
Summary
This phase I/II clinical trial evaluates the safety, efficacy, and prognostic potential of \[18F\]AlF-NOTA-PCP2 PET/CT imaging in assessing PD-L1 expression in malignant tumors, including glioblastoma, head and neck squamous cell carcinoma, non-small cell lung cancer, and esophageal cancer. The primary aim is to establish the correlation between \[18F\]AlF-NOTA-PCP2 uptake and PD-L1 expression in tumor tissues, while secondary objectives include evaluating its role in predicting clinical outcomes such as progression-free survival (PFS) and overall survival (OS). By providing a non-invasive, quantitative, and reproducible method for assessing PD-L1, this study aims to refine patient stratification and improve the precision of immunotherapy decision-making.
Official title: Evaluation of the Value of [18F]AlF-NOTA-PCP2 PET/CT for PD-L1 Detection in Malignant Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2024-03-30
Completion Date
2026-10-31
Last Updated
2025-03-30
Healthy Volunteers
No
Conditions
Interventions
PET/CT ([18F]AlF-NOTA-PCP2)
This intervention involves the use of \[18F\]AlF-NOTA-PCP2, a radiopharmaceutical agent specifically designed for PET/CT imaging. Patients will receive an intravenous injection of \[18F\]AlF-NOTA-PCP2, followed by whole-body PET/CT scanning one hour later. The primary purpose of this intervention is to assess PD-L1 expression in malignant tumors, including glioblastoma, head and neck squamous cell carcinoma, non-small cell lung cancer, and esophageal cancer, before the initiation of treatment. This imaging technique offers a non-invasive, repeatable, and comprehensive method to monitor PD-L1 status, in contrast to traditional tissue biopsy, which is invasive and limited to a single time point.
[18F]AlF-NOTA-PCP2 PET/CT Imaging for PD-L1 Expression in Malignant Tumors
This intervention involves the use of \[18F\]AlF-NOTA-PCP2, a radiopharmaceutical agent specifically designed for PET/CT imaging. Patients will receive an intravenous injection of \[18F\]AlF-NOTA-PCP2, followed by whole-body PET/CT scanning one hour later. The primary purpose of this intervention is to assess PD-L1 expression in malignant tumors, including glioblastoma, head and neck squamous cell carcinoma, non-small cell lung cancer, and esophageal cancer, before the initiation of treatment. This imaging technique offers a non-invasive, repeatable, and comprehensive method to monitor PD-L1 status, in contrast to traditional tissue biopsy, which is invasive and limited to a single time point.
Locations (1)
Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
Jinan, Shandong, China