Study on the single dose toxicity of PET bone imaging agent sodium [¹⁸F] fluoride

Sodium [¹⁸F] fluoride injection is a radioactive diagnostic agent for positron emission tomography (PET) indicated for imaging of bone to define areas of altered osteogenic activity. Its toxicity is an important data of the drug safety. In this study, in order to investigate the single dose toxicity of sodium [¹⁸F] fluoride injection, SD rats were divided into high doses group, low doses group and a control group, then sodium [¹⁸F] fluoride injection were administered through the tail vein one time. The changes of animal weight, feed consumption, hematological indexes and toxic symptoms were observed at different time. Finally, dissection examination and pathological examination were performed, and the experimental data were statistically analyzed. The experimental results showed that: compared with the control group, there was no statistical difference in the weight of the rats in the high-dose groups and low-dose groups at the 7 th and 14 th day after the administration, and there was no statistical difference in the weight of the spleen, kidney and testicles of the rats and feed consumption at 14 days after the administration. There was no significant difference in blood biochemical indexes of three groups at the 0, 8 th and 14 th day after administration. After administration 14 days,no toxic reaction or animal death occurred, no abnormalities were found in the size, color, texture and pathological examination of tissues and organs. No significant toxic reaction was observed in the rats after 14 days the administration of sodium [¹⁸F] fluoride injection with 15.7 times of the maximum clinical dose and the average clinical dose. This experiment provided important safety reference data for the clinical use of this imaging agent. (authors)