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Purpose <p>This study aimed to establish a fully automated radiosynthesis procedure for [<sup>18</sup>F] AlF-NOTA-FAPI-04 using the CFN200 multifunctional module, optimize key reaction parameters to improve labeling efficiency, and preliminarily validate its in vivo biological affinity and quality via a translational proof-of-concept PET/CT study.</p> Methods <p>Reaction parameters including precursor amount, AlCl₃ volume, reaction temperature and reaction time were sequentially evaluated and optimized. Quality control including appearance, pH, radiochemical purity, radionuclidic identity, activity, bacterial endotoxins, sterility, ethanol content and residual acetonitrile were performed. Preliminary PET/CT imaging was conducted in a patient with pancreatic cancer for comparison with [<sup>18</sup>F] FDG. The study was registered with the Chinese Clinical Trial Registry (ChiCTR2300077391).</p> Results <p>The total synthesis time was approximately 25&#xa0;min, yielding a decay-corrected radiochemical yield of 29.38 ± 3.3% (decay-corrected to end of synthesis) with RCP &gt; 99%. Quality control results met all pharmacopeial specifications. Preliminary imaging showed that [<sup>18</sup>F] AlF-NOTA-FAPI-04 provided higher tumor-to-background contrast than [<sup>18</sup>F] FDG and detected more metastatic lesions.</p> Conclusion <p>This automated synthesis of [<sup>18</sup>F] AlF-NOTA-FAPI-04 based on the CFN200 module is reliable and efficient. The tracer exhibits favorable imaging characteristics and high tumor uptake, supporting its potential as a promising FAP-targeted PET agent for clinical oncological applications.</p>

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Optimization of the Radiosynthesis of [18F] AlF-NOTA-FAPI-04 Based on CFN200 Multifunctional Synthesis Module and PET/CT Imaging

  • 期刊论文

  • 发表日期：

    2026年8月3日

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  • Yuhui Luo,
  • Yousheng Zhan,
  • Hao Zhang,
  • Fei Luo,
  • Chengyu Luo,
  • Jie Li,
  • Suping Li

摘要

Purpose

This study aimed to establish a fully automated radiosynthesis procedure for [18F] AlF-NOTA-FAPI-04 using the CFN200 multifunctional module, optimize key reaction parameters to improve labeling efficiency, and preliminarily validate its in vivo biological affinity and quality via a translational proof-of-concept PET/CT study.

Methods

Reaction parameters including precursor amount, AlCl₃ volume, reaction temperature and reaction time were sequentially evaluated and optimized. Quality control including appearance, pH, radiochemical purity, radionuclidic identity, activity, bacterial endotoxins, sterility, ethanol content and residual acetonitrile were performed. Preliminary PET/CT imaging was conducted in a patient with pancreatic cancer for comparison with [18F] FDG. The study was registered with the Chinese Clinical Trial Registry (ChiCTR2300077391).

Results

The total synthesis time was approximately 25 min, yielding a decay-corrected radiochemical yield of 29.38 ± 3.3% (decay-corrected to end of synthesis) with RCP > 99%. Quality control results met all pharmacopeial specifications. Preliminary imaging showed that [18F] AlF-NOTA-FAPI-04 provided higher tumor-to-background contrast than [18F] FDG and detected more metastatic lesions.

Conclusion

This automated synthesis of [18F] AlF-NOTA-FAPI-04 based on the CFN200 module is reliable and efficient. The tracer exhibits favorable imaging characteristics and high tumor uptake, supporting its potential as a promising FAP-targeted PET agent for clinical oncological applications.