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Clinical Application of PET Imaging Targeting CLDN18.2 in Malignant Tumors
Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Summary
The project aims to perform integrated PET/MR or PET/CT imaging in patients with histologically confirmed or clinically suspected gastric cancer, pancreatic cancer, cholangiocarcinoma, or other malignant tumors with high Claudin18.2 (CLDN18.2) expression, as well as healthy volunteers. This study utilizes a CLDN18.2-specific PET imaging probe (e.g., \[\^68Ga\]Ga-labeled humanized antibody fragment) to evaluate the feasibility, accuracy, and clinical value of non-invasive, in vivo CLDN18.2 visualization. For patients with malignant tumors, the study will assess the diagnostic performance of CLDN18.2-targeted PET in identifying tumor lesions, compare the imaging results with gold-standard histopathology, determine the location, extent, and metabolic features of CLDN18.2-positive lesions, and evaluate tumor burden and treatment stratification value compared with \[\^18F\]FDG PET imaging. These results may assist in patient selection for CLDN18.2-targeted therapies (e.g., Zolbetuximab), guide clinical decision-making, and provide early prediction of therapeutic response. For healthy volunteers, pharmacokinetic profiling will be conducted to investigate the biodistribution, clearance, and safety of the radiotracer in vivo.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
56
Start Date
2025-09-01
Completion Date
2026-12-31
Last Updated
2025-12-24
Healthy Volunteers
Yes
Interventions
Specific PET imaging agents targeting CLDN18.2
The project aims to perform integrated PET/MR or PET/CT imaging in patients with histologically confirmed or clinically suspected gastric cancer, pancreatic cancer, cholangiocarcinoma, or other malignant tumors with high Claudin18.2 (CLDN18.2) expression, as well as healthy volunteers. This study utilizes a CLDN18.2-specific PET imaging probe (e.g., \[\^68Ga\]Ga-labeled humanized antibody fragment) to evaluate the feasibility, accuracy, and clinical value of non-invasive, in vivo CLDN18.2 visualization.
Locations (1)
Wuhan Union Hospital, China
Wuhan, Hubei, China