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Positron Emission Tomography (PET) is a medical imaging technique that provides crucial insights into the body's physiological functions at a molecular level. It is an indispensable resource for diagnosing, staging, and monitoring various illnesses, notably cancer, neurological disorders, and cardiovascular conditions.
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Investigations on the GaIII Complex of EOB-DTPA and Its 68Ga Radiolabeled Analogue
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[68Ga]Ga-DOTA-TOC Synthesis by a Cassette Developer System with [68Ga]GaCl3 from Cyclotron using Liquid Target: An

Michela Cossandi1, Massimo Statuto1, Giorgio Biasiotto2

  • 1Nuclear Medicine, ASST Spedali Civili di Brescia, Brescia, Italy.

Current Radiopharmaceuticals
|May 12, 2025
PubMed
Summary

Cyclotron production of Gallium-68 (68Ga)-DOTA-TOC offers an alternative to costly generators for detecting neuroendocrine tumors. Optimization has led to a 0% failure rate, improving radiopharmaceutical accessibility.

Keywords:
Cyclotron[68Ga]Ga-DOTA-TOCeuropean pharmacopeia.gastroenteropancreatic neuroendocrine tumorsgeneratorliquid targetpositron emission tomographyradiopharmaceutical

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Area of Science:

  • Nuclear Medicine
  • Radiopharmaceutical Chemistry

Background:

  • [68Ga-DOTA-D-Phe1-Tyr3]octreotide ([68Ga]Ga-DOTA-TOC) is a key somatostatin analogue for PET/CT imaging of gastroenteropancreatic neuroendocrine tumors (GEP-NET).
  • Traditional production relies on 68Ge/68Ga generators, which are becoming increasingly expensive due to Good Manufacturing Practice (GMP) compliance costs.

Purpose of the Study:

  • To optimize the production of [68Ga]Ga-DOTA-TOC using a cyclotron-based method.
  • To present findings from three years of experience in cyclotron production of this radiopharmaceutical.

Main Methods:

  • Optimized production of Gallium-68 (68Ga) chloride via the 68Zn(p,n)68Ga reaction using a PETtrace 800 cyclotron with a liquid ZnO target.
  • Synthesized [68Ga]Ga-DOTA-TOC using the FASTlab2 system, adhering to current Good Radiopharmacy Practice (cGRPP) guidelines.
  • Validated quality control processes against the European Pharmacopoeia monograph (2482) for clinical use.

Main Results:

  • Achieved [68Ga]Ga-DOTA-TOC production within 40 minutes, with ten validation batches meeting European Pharmacopoeia quality standards.
  • Addressed synthesis challenges, including corrosion from acidic reagents, which initially caused a 12.2% failure rate and target breakdown after 11 months.
  • Implemented troubleshooting strategies, successfully reducing failures to achieve a 0% failure rate.

Conclusions:

  • Cyclotron production of [68Ga]Ga-DOTA-TOC is a viable and advantageous alternative to 68Ge/68Ga generators.
  • Consolidated liquid target production offers significant benefits for radiopharmaceutical supply.
  • The optimized process ensures reliable and high-quality production of [68Ga]Ga-DOTA-TOC.