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Updated: Sep 12, 2025
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Published on: September 21, 2021
Automated Radiosynthesis of [18F]Fluoromannitol for Clinical Research on a Commercially Available Trasis AllinOne
Amy L Vavere1, Allison J Clay1, Arijit Ghosh1
1St Jude Children's Research Hospital.
Background:
Infections pose a significant risk to immunocompromised individuals, and accurate, efficient diagnosis remain challenging. Current imaging methods like MRI and FDG PET lack pathogen specificity which complicate diagnosis and lead to overuse of antibiotics. Recent data shows that [18F]fluoromannitol ([18F]FMtl) is sensitive and specific to infection in vivo by exploiting the pathogen-specific mannitol transporter. This work aims to establish a reliable, automated method for producing [18F]fluoromannitol to facilitate clinical research studies in human subjects.
Results:
This study optimized and automated the radiosynthesis of [18F]fluoromannitol ([18F]FMtl) on a Trasis AllinOne synthesizer. The 105-minute synthesis achieved an average yield of 11.0% (n=19) with >97% radiochemical purity, and the product remained stable for at least 8 hours. While yield was lower than the previously reported manual method, automation enabled reproducibility and sterility. Process improvements included optimizing evaporation steps and reaction temperature, which significantly increased fluorine incorporation and yield. The process was validated to meet USP <823> regulatory requirements including full QC testing on three consecutive batches.
Conclusions:
An automated method for the radiochemical synthesis of [18F]fluoromannitol was developed and optimized on a commercially available Trasis AllinOne radiosynthesizer. This method allows for the reliable production and global dissemination of [18F]FMtl for use in clinical research trials.
Insights
Automated production of [18F]fluoromannitol ([18F]FMtl) offers a reliable method for infection imaging. This new process ensures sterile, reproducible synthesis for enhanced clinical research and diagnosis in immunocompromised patients.
Area of Science:
- Radiochemistry
- Medical Imaging
- Nuclear Medicine
Background:
- Infections present a significant diagnostic challenge in immunocompromised individuals.
- Current imaging modalities like MRI and FDG PET lack pathogen specificity, leading to diagnostic delays and antibiotic overuse.
- [18F]fluoromannitol ([18F]FMtl) shows promise for infection detection due to its specificity for pathogen-expressed mannitol transporters.
Purpose of the Study:
- To develop and optimize a reliable, automated radiosynthesis method for [18F]fluoromannitol ([18F]FMtl).
- To facilitate the clinical research and potential diagnostic application of [18F]FMtl in human subjects.
Main Methods:
- Radiosynthesis of [18F]FMtl was optimized and automated using a Trasis AllinOne synthesizer.
- Key process parameters including evaporation and reaction temperature were refined to enhance fluorine incorporation and yield.
- The automated synthesis was validated against USP <823> regulatory standards, including comprehensive quality control testing.
Main Results:
- The automated 105-minute synthesis yielded an average of 11.0% [18F]FMtl with >97% radiochemical purity.
- The synthesized [18F]FMtl demonstrated stability for at least 8 hours post-synthesis.
- Process optimization significantly improved fluorine incorporation and overall yield compared to initial automated runs.
Conclusions:
- A reproducible and sterile automated method for [18F]fluoromannitol ([18F]FMtl) radiochemical synthesis was successfully established.
- This automated process on a commercial synthesizer enables reliable production and potential global dissemination of [18F]FMtl for clinical research.
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