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.

Research Square
|August 6, 2025
PubMed
Abstract

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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