MedicineEngineeringEnvironmental Science

Alessandra Guercio, T. Martin, S. Migliari, Anna Gagliardi, M. Scarlattei, Giorgio Baldari, Nicolas Martelli, Livia Ruffini

2026.3.13EJNMMI Radiopharmacy and Chemistry

DOI: 10.1186/s41181-026-00437-z

Resumen de tlooto

The 68Ge/68Ga generator supports reliable, sustainable, and cost-effective radiopharmaceutical production, enhancing efficiency and clinical capacity in PET imaging.

Resumen

Background Sustainability in healthcare, particularly Nuclear Medicine, is essential, especially in managing radioactive materials. Traditional centralized production of Fluorine-18 tracers for PET imaging faces challenges like transport logistics, decay losses and supply chain vulnerabilities. Decentralized production with radionuclide generators, such as the Germanium-68/Gallium-68 (68Ge/68Ga) generator, offers on-demand isotope production, improving accessibility and precision imaging. This study evaluates the long-term performance (8 years) of 68Ga-based radiopharmaceutical production in a Nuclear Medicine Division, focusing on efficiency, sustainability, and cost. Results Between 2016 and 2024, 416 batches of 68GaCl₃ and 2455 batches of 68Ga-based radiopharmaceuticals were produced. Data from systematic quality controls on generator eluates and tracers, such as 68Ga-PSMA (1800 batches) and 68Ga-DOTATOC (610 batches), were evaluated. All 68GaCl₃ eluates met Ph. Eur. specifications, with negligible 68Ge breakthrough (mean 0.0000068%) and consistently high radiochemical purity (100%). Radiopharmaceuticals showed stable quality over time, with > 98% purity for 68Ga-DOTATOC and > 99% for 68Ga-PSMA. Generators performance remained reliable, with an average elution yield of 74.8% (range 63.4–84.7%) and up to 466 elutions/year reached in 2024 without quality degradation. The correlation between estimated and measured end-of-synthesis activities was strong (R2 ≈ 1), supporting accurate production planning. Clinical PET scans increased over sixfold, from 144 in 2016 to 920 in 2025. The high-sensitivity PET/CT system helped reduce injected activity and acquisition time, improving throughput and sustaining growth. The clinical-to-production ratio progressively decreased from 1 (1 batch/exam) to 0.42 for 68Ga-PSMA (range 0.37–0.51) and 0.49 for 68Ga-DOTATOC (range 0.40–0.60), indicating better batch utilization and workflow efficiency. Cost analysis showed module-based synthesis was most efficient during high-yield phases of the generators, while kit-based approaches were more cost-effective at later stages. Supply logistics of precursors and reagents has shown to be more sustainable for in-house production of radiopharmaceuticals compared to the purchased ones from external facilities. Conclusions The 68Ge/68Ga generator supports reliable, sustainable, and cost-effective radiopharmaceutical production, enhancing efficiency and clinical capacity in PET imaging. Supplementary Information The online version contains supplementary material available at 10.1186/s41181-026-00437-z.

Formato de cita

GUERCIO, Alessandra, et al. The 68ge/68ga generator for enhancing productivity and reducing costs in nuclear medicine: Experience from a university hospital. EJNMMI Radiopharmacy and Chemistry, 2026, 11(1).