Wuhan Union Hospital, China
Wuhan, Hubei, 430030, China
Location status: Recruiting
NCT Number: NCT07301814
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Wuhan, Hubei, 430030, China
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 1 year
At least two experienced nuclear medicine physicians will conduct a visual analysis using consensus reading. The standardized uptake value (SUV) of the tumor and organs will be measured after a semiquantitative analysis is performed for each case. The SUV ranges from 0 to infinity, and a higher score means a higher uptake of targeting CLDN18.2 nuclear probe by the tumor, which implies a greater threat of the tumor being malignant or a higher stage.
Time frame: 1 year
Blood samples were collected at 25 minutes, 55 minutes and 115 minutes after injection.
Time frame: 1 year
The excised tumour tissue was taken for immunohistochemistry to verify its CLDN18.2 expression
Contact information is provided by the study sponsor or research team.
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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