Comparison of FASTlab 18F-FDG Production Using Phosphate and Citrate Buffer Cassettes

Journal of Nuclear Medicine Technology

Mark S. Jacobson¹  Joseph C. Hung¹  James Z. Long¹ 

[1] Department of Radiology, Mayo Clinic, Rochester, Minnesota Department of Radiology, Mayo Clinic, Rochester, Minnesota Department of Radiology, Mayo Clinic, Rochester, Minnesota

关键词: PET radiochemistry;    ¹⁸F-FDG;    radiopharmacy;    quality control;   

DOI  :  10.2967/jnmt.112.112649

学科分类：医学（综合）

来源: Society of Nuclear Medicine

【 摘 要 】

The objective of this research is to determine whether there are significant differences in the 18F-FDG produced by either the phosphate or the citrate buffer cassettes in the FASTlab synthesizer. Methods: Forty batches of 18F-FDG were produced with each cassette and analyzed retrospectively. The analysis consisted of determining the mean radiochemical yield (RCY)uncorrected and corrected for decayradiochemical purity (RCP), pH, and residual solvent content (ethanol and acetonitrile). An independent t test (alpha error [α], 0.05) was performed to determine whether the differences were statistically significant. Results: The mean decay-corrected RCYs for 18F-FDG produced by phosphate and citrate cassettes were 82.9% ± 17.4% and 79.2% ± 5.0%, respectively. The uncorrected RCY was 57.5% ± 16.7% for phosphate- and 58.8% ± 6.0% for citrate-buffered 18F-FDG, leading to a difference of 4.4% and P value of 0.11 for corrected RCY and a difference of 2.2% and P value of 0.32 for uncorrected RCY. Thus, the RCY differences are neither statistically nor clinically significant. The mean RCPs were 99.4% ± 0.2% for the phosphate-buffered 18F-FDG and 99.0% ± 1.1% for the citrate-buffered 18F-FDG. There was a 0.5% difference and a P value of 0.021, meaning that the difference was statistically significant. The average pHs for 18F-FDG produced by phosphate and citrate buffer cassettes were 5.9 ± 0.1 and 5.3 ± 0.2, respectively, resulting in a 9.6% difference and a P value close to zero (2.6 × 10−19)a statistically significant difference. The difference between ethanol content was also dramatic. Phosphate-buffered 18F-FDG contained 0.08% ± 0.02% ethanol, whereas the citrate-buffered 18F-FDG contained 0.20% ± 0.07%. No difference was found in the acetonitrile content of the 2 cassettes. Conclusion: The differences in yield between cassettes are due to statistical variability. The results confirm our hypothesis that there is no significant difference in RCY. The differences seen in the statistically significant data (those with a P value > 0.05) turn out to be insignificant in a real-world setting because all values fell within the limits set by the United States Pharmacopeia and Food and Drug Administration. Therefore, determining which cassette to use is a matter of the preference of the institution.

【 授权许可】

Unknown