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- W3204350525 abstract "2730 Objectives GE Healthcare’s FASTlab FDG synthesizer is utilized in producing bulk [18F]FDG. There are two cassette types, one in which the [18F]FDG solution is diluted in 15 mL phosphate buffer, and the other in 29 mL of sodium citrate solution. The cassettes include all the necessary components for synthesis of [18F]FDG. The synthesis is controlled and monitored with vendor supplied computer software, reducing exposure to the operator. The objective of this research is to determine if there are significant differences in the [18F]FDG produced by either cassette. Methods Data for 80 batches of [18F]FDG were analyzed retrospectively: 40 batches produced with each cassette. The analysis consisted of determining the mean radiochemical yield (RCY, corrected for decay), radiochemical purity (RCP), and performing an independent T-test (α = 0.05) to determine if the differences were statistically significant. Results The mean decay corrected RCY for the phosphate and citrate cassettes were 82.9 ± 17.4% ([18F]FDG - 3.6 Ci [range 1.6 - 7.1 Ci]) and 79.2 ± 5.0% ([18F]FDG - 3.6 Ci [range 1.1 - 6.6 Ci]), respectively. This led to a difference of 4.4% and a P value of 0.11, meaning the differences observed were statistically insignificant. The mean RCP for the phosphate cassette was 99.4 ± 0.2% and 99.0 ± 1.1% for the citrate. There was a percent difference of 0.5% and a P value of 0.021, meaning the difference was statistically significant. Conclusions The differences in yield between cassettes are due to statistical variability. The results confirm our opinion that there is no significant difference in RCY. The deviation seen in RCP is dependent on the cassette used since the P value is less than 0.05. However, with a difference of 0.5%, it is insignificant since the value falls within the 90.0% minimum limit set by the United States Pharmacopeia. Therefore, determining which cassette to use is a matter of preference for the institution. Our initial experience has shown a number of citrate cassette catastrophic failures. We are currently working with GE Healthcare to resolve these issues" @default.
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- W3204350525 date "2012-05-01" @default.
- W3204350525 modified "2023-09-23" @default.
- W3204350525 title "Comparison of FASTlab [18F]FDG production using phosphate and sodium citrate buffer cassettes" @default.
- W3204350525 hasPublicationYear "2012" @default.
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