subgroups mass does escalation

Perform whole-body PET/CT scans on the subjects at 30 minutes (± 5 minutes), 60 minutes (± 10 minutes), 120 minutes (± 20 minutes), and 240 minutes (± 30 minutes) after administration. Among them, PET scanning can be performed on 1-2 subjects in a certain dose group or each dose group for 30-60 minutes. Among the four CT scans, one CT scan is a conventional low-dose CT scan (120mA), and the remaining three are extremely low-dose CT scans (10-20mA). The main researchers and nuclear medicine physicians can decide whether to change the subsequent image acquisition time and duration of the subjects based on the image information obtained from the enrolled subjects.

Evaluate the biological distribution characteristics of important organs in the subjects.

• Draw the Volume of Interest (VOI) of the subject's vital organs and calculate the Percentage of Injected Activity (IA) of the vital organs
• Using PMOD software, manually draw regions of interest (VOI) on PET/CT images of the liver, spleen, normal stomach, heart, bone marrow, kidneys, and other areas to obtain the cumulative radioactive activity of these regions. Divide the cumulative radioactive activity by the injection dose to obtain the percentage of injection activity (% IA).

AE/SAE/SUSAR

Detect the radiation dose of whole blood and serum of the subjects, and calculate the absorbed dose of important organs

Correlation analysis between PET/CT imaging features of target lesions (SUVmax, SUV mean, target to body ratio, etc.) and CLDN18.2IHC expression level (if any)