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An Automated Radiosynthesis of [68Ga]Ga-FAPI-46 for Routine Clinical Use

作者： Laurence Morandeau1, Joseph A. Ioppolo1,2, Eva Alvarez de Eulate1, Shifaza Mohamed1, Danica Cullen1, Ali H. Asad1, Roslyn J. Francis2,3,4, Janette Atkinson1 1Radiopharmaceutical Production and Development Centre (RAPID), Medical Technology and Physics Department,Sir Charles Gairdner Hospital, 2National Imaging Facility, Centre for Microscopy, Characterisation and Analysis,University of Western Australia, 3Department of Nuclear Medicine,Sir Charles Gairdner Hospital, 4Medical School,University of Western Australia
简介：

Overview

This method presents the automated production of the positron emission tomography (PET) tracer gallium-68 FAPI-46 on the iPHASE MultiSyn synthesizer. Gallium-68 FAPI-46 targets fibroblast activation protein (FAP), which is over-expressed by cancer-associated fibroblasts in solid tumors.

Key Study Components

Area of Science

  • Neuroscience
  • Oncology
  • Medical Imaging

Background

  • Gallium-68 FAPI-46 is a novel PET imaging tracer.
  • FAP is a marker for cancer-associated fibroblasts.
  • It has shown diagnostic advantages over fluorine-18 FDG in multiple cancers.
  • Automated synthesis reduces radiation risk and improves compliance with GMP.

Purpose of Study

  • To automate the production of gallium-68 FAPI-46 for PET imaging.
  • To enhance the safety and efficiency of tracer production.
  • To provide a reliable method for cancer imaging.

Methods Used

  • Automated synthesis on the iPHASE MultiSyn synthesizer.
  • Utilization of generator produced and cyclotron produced gallium-68.
  • Compliance with Good Manufacturing Practice (GMP) standards.
  • Evaluation of tracer efficacy in imaging cancer-associated fibroblasts.

Main Results

  • Production of up to 1.7 GBq of gallium-68 FAPI-46.
  • Demonstrated safety and efficiency of automated synthesis.
  • Confirmed the tracer's potential in cancer diagnostics.
  • Showed advantages over traditional methods of synthesis.

Conclusions

  • Automated production of gallium-68 FAPI-46 is feasible and effective.
  • This method enhances safety for personnel involved in tracer production.
  • Gallium-68 FAPI-46 is a promising tool for PET imaging in oncology.

Frequently Asked Questions

What is gallium-68 FAPI-46?
Gallium-68 FAPI-46 is a PET imaging tracer that targets fibroblast activation protein, which is over-expressed in many solid tumors.
Why is automated synthesis important?
Automated synthesis reduces radiation exposure for personnel and ensures compliance with Good Manufacturing Practices.
What are the advantages of gallium-68 FAPI-46 over FDG?
Gallium-68 FAPI-46 has shown diagnostic advantages in imaging cancer-associated fibroblasts compared to the standard fluorine-18 FDG.
How much gallium-68 FAPI-46 can be produced?
The automated method can produce up to 1.7 GBq of gallium-68 FAPI-46.
What synthesizer is used for the production?
The iPHASE MultiSyn synthesizer is used for the automated production of gallium-68 FAPI-46.
Is this method compliant with regulations?
Yes, the automated synthesis method is compliant with Good Manufacturing Practices (GMP).

This work describes the automated production of up to 1.7 GBq of [68Ga]Ga-FAPI-46 on the iPHASE MultiSyn synthesizer for PET imaging of fibroblast activation protein.

标签: Automated Radiosynthesis,    [68Ga]Ga-FAPI-46,    Fibroblast Activation Protein,    Positron Emission Tomography,    Imaging Tracer,    Cancer Imaging,    Pharmacokinetic Properties,    Tumor Retention,    FDG-PET,    Solid Phase Extraction,    Clinical Applications,    Production Optimization,    Quality Control Specifications,   
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