To systematically evaluate the efficacy and safety of radiopharmaceutical 18F-FDG provided by Shanghai Kexing Pharmaceutical Corporation

a multicenter study of FDG-PET imaging was conducted at 3 hospitals in 2003. The sterile aqueous solution of 18F-FDG was injected to patients before five items of determination including specific activity

pH

radiochemical purity

bacterial endotoxins were completed. The quality control of 18F-FDG aqueous solution is found to be efficient and so the agent is safe. Average radiochemical purity is 95.7% and is still no less than 90% after 9 hours. Moreover

FDG-PET imaging is very clear and none of 65 patients showed any bad reaction. Diagnostic conclusions accorded with the last clinical diagnosis for most patients (89.23%)

though there are still a few false positive cases (4.61%) and false negative cases (6.15%). It is feasible that 18F-FDG produced by PET Center equipped with cyclotron and hot cell could be used in the nearby hospitals.