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Updated: Jun 24, 2025

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

Laurence Morandeau1, Joseph A Ioppolo2, Eva Alvarez de Eulate3

  • 1Radiopharmaceutical Production and Development Centre (RAPID), Medical Technology and Physics Department, Sir Charles Gairdner Hospital; laurence.morandeau@health.wa.gov.au.

Journal of Visualized Experiments : Jove
|June 10, 2024
PubMed
Summary
This summary is machine-generated.

Automated synthesis of Gallium-68 labeled fibroblast activation protein inhibitor ( [68Ga]Ga-FAPI-46 ) was developed for clinical positron emission tomography (PET) imaging. This method provides high yield and purity for cancer diagnostics.

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Area of Science:

  • Radiochemistry
  • Nuclear Medicine
  • Oncology

Background:

  • Fibroblast activation protein (FAP) imaging using positron emission tomography (PET) tracers like [68Ga]Ga-FAPI-46 shows promise for various cancers.
  • FAPI-PET offers advantages over FDG-PET, including no fasting or resting requirements.
  • [68Ga]Ga-FAPI-46 demonstrates superior pharmacokinetic properties and image contrast compared to earlier FAPI tracers.

Purpose of the Study:

  • To develop and validate an automated synthesis of [68Ga]Ga-FAPI-46 for clinical applications.
  • To optimize reaction conditions and purification methods for efficient production.

Main Methods:

  • Development of an automated synthesis of [68Ga]Ga-FAPI-46 using the iPHASE MultiSyn synthesizer.
  • Optimization of reaction time and evaluation of four solid phase extraction (SPE) cartridges for purification.
  • Validation of production parameters for generating 0.6-1.7 GBq of the tracer.

Main Results:

  • The automated synthesis achieved a decay-corrected yield of 89.8 ± 4.8% (n=6) within 25 minutes.
  • The final product met all quality control specifications.
  • The synthesized [68Ga]Ga-FAPI-46 remained stable for up to 3 hours post-synthesis.

Conclusions:

  • An efficient and reliable automated synthesis method for [68Ga]Ga-FAPI-46 has been established for clinical use.
  • This automated process facilitates the routine production of high-quality [68Ga]Ga-FAPI-46 for FAP-targeted PET imaging in oncology.