Automated Pet Radiotracer Manufacture On The Bg75 System And Imaging Validation Studies Of [F-18]Fluoromisonidazole ([F-18]Fmiso)

Background and Objective: The hypoxia PET tracer, 1-[F-18] fluoro-3-(2-nitro-1Himidazol- 1-yl)-propan-2-ol ([F-18] FMISO) is the first radiotracer developed for hypoxia PET imaging and has shown promising for cancer diagnosis and prognosis. However, access to [F-18] FMISO radiotracer is limited due to the needed cyclotron and radiochemistry expertise. The study aimed to develop the automated production method on the [F-18] FMISO radiotracer with the novel fully automated platform of the BG75 system and validate its usage on animal tumor models.Method: [F-18] FMISO was produced with the dose synthesis cartridge automatically on the BG75 system. Validation of [F-18] FMISO hypoxia imaging functionality was conducted on two tumor mouse models (FaDu/U87 tumor). The distribution of [F-18] FMISO within tumor was further validated by the standard hypoxia marker EF5.Results: The average radiochemical purity was (99 +/- 1) % and the average pH was 5.5 +/- 0.2 with other quality attributes passing standard criteria (n=12). Overall biodistribution for [F-18] FMISO in both tumor models was consistent with reported studies where bladder and large intestines presented highest activity at 90 min post injection. High spatial correlation was found between [F-18] FMISO autoradiography and EF5 hypoxia staining, indicating high hypoxia specificity of [F-18] FMISO.Conclusion: This study shows that qualified [F-18] FMISO can be efficiently produced on the BG75 system in an automated "dose-on-demand" mode using single dose disposable cards. The possibilities of having a low-cost, automated system manufacturing ([F-18] Fluoride production + synthesis + QC) different radiotracers will greatly enhance the potential for PET technology to reach new geographical areas and underserved patient populations.