Background and Objective: The hypoxia PET tracer, 1-[18F]fluoro-3-(2-nitro-1Himidazol-
1-yl)-propan-2-ol ([18F]FMISO) is the first radiotracer developed for hypoxia PET imaging
and has shown promising for cancer diagnosis and prognosis. However, access to [18F]FMISO radiotracer
is limited due to the needed cyclotron and radiochemistry expertise. The study aimed to develop
the automated production method on the [18F]FMISO radiotracer with the novel fully automated
platform of the BG75 system and validate its usage on animal tumor models.
Method: [18F]FMISO was produced with the dose synthesis cartridge automatically on the BG75
system. Validation of [18F]FMISO hypoxia imaging functionality was conducted on two tumor
mouse models (FaDu/U87 tumor). The distribution of [18F]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 [18F]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 [18F]FMISO
autoradiography and EF5 hypoxia staining, indicating high hypoxia specificity of [18MF]FMISO.
Conclusion: This study shows that qualified [18F]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 ([18F]Fluoride production + synthesis +
QC) different radiotracers will greatly enhance the potential for PET technology to reach new geographical
areas and underserved patient populations.