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Multi-curie production of gallium-68 on a biomedical cyclotron and automated radiolabelling of PSMA-11 and DOTATATE.

作者信息

Thisgaard Helge, Kumlin Joel, Langkjær Niels, Chua Jansen, Hook Brian, Jensen Mikael, Kassaian Amir, Zeisler Stefan, Borjian Sogol, Cross Michael, Schaffer Paul, Dam Johan Hygum

机构信息

Department of Nuclear Medicine, Odense University Hospital, Kløvervænget 47, 5000, Odense, Denmark.

Department of Clinical Research, University of Southern Denmark, Odense, Denmark.

出版信息

EJNMMI Radiopharm Chem. 2021 Jan 7;6(1):1. doi: 10.1186/s41181-020-00114-9.


DOI:10.1186/s41181-020-00114-9
PMID:33411034
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7790954/
Abstract

BACKGROUND: With increasing clinical demand for gallium-68, commercial germanium-68/gallium-68 ([Ge]Ge/[Ga]Ga) generators are incapable of supplying sufficient amounts of the short-lived daughter isotope. In this study, we demonstrate a high-yield, automated method for producing multi-Curie levels of [Ga]GaCl from solid zinc-68 targets and subsequent labelling to produce clinical-grade [Ga]Ga-PSMA-11 and [Ga]Ga-DOTATATE. RESULTS: Enriched zinc-68 targets were irradiated at up to 80 µA with 13 MeV protons for 120 min; repeatedly producing up to 194 GBq (5.24 Ci) of purified gallium-68 in the form of [Ga]GaCl at the end of purification (EOP) from an expected > 370 GBq (> 10 Ci) at end of bombardment. A fully automated dissolution/separation process was completed in 35 min. Isolated product was analysed according to the Ph. Eur. monograph for accelerator produced [Ga]GaCl and found to comply with all specifications. In every instance, the radiochemical purity exceeded 99.9% and importantly, the radionuclidic purity was sufficient to allow for a shelf-life of up to 7 h based on this metric alone. Fully automated production of up to 72.2 GBq [Ga]Ga-PSMA-11 was performed, providing a product with high radiochemical purity (> 98.2%) and very high apparent molar activities of up to 722 MBq/nmol. Further, manual radiolabelling of up to 3.2 GBq DOTATATE was performed in high yields (> 95%) and with apparent molar activities (9-25 MBq/nmol) sufficient for clinical use. CONCLUSIONS: We have developed a high-yielding, automated method for the production of very high amounts of [Ga]GaCl, sufficient to supply proximal radiopharmacies. The reported method led to record-high purified gallium-68 activities (194 GBq at end of purification) and subsequent labelling of PSMA-11 and DOTATATE. The process was highly automated from irradiation through to formulation of the product, and as such comprised a high level of radiation protection. The quality control results obtained for both [Ga]GaCl for radiolabelling and [Ga]Ga-PSMA-11 are promising for clinical use.

摘要
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff53/7790954/2ef48c6d0a42/41181_2020_114_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff53/7790954/7881e8b7c663/41181_2020_114_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff53/7790954/6669d7865458/41181_2020_114_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff53/7790954/2ef48c6d0a42/41181_2020_114_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff53/7790954/7881e8b7c663/41181_2020_114_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff53/7790954/6669d7865458/41181_2020_114_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff53/7790954/2ef48c6d0a42/41181_2020_114_Fig3_HTML.jpg

相似文献

[1]
Multi-curie production of gallium-68 on a biomedical cyclotron and automated radiolabelling of PSMA-11 and DOTATATE.

EJNMMI Radiopharm Chem. 2021-1-7

[2]
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[3]
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[4]
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[5]
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[6]
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[7]
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[8]
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[9]
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[10]
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引用本文的文献

[1]
Ga Extemporaneous Preparations in Radiopharmacy.

Pharmaceutics. 2025-6-20

[2]
[Ga]Ga-DOTA-TOC Synthesis by a Cassette Developer System with [Ga]GaCl from Cyclotron using Liquid Target: An Italian Experience.

Curr Radiopharm. 2025

[3]
A comparison of routine [Ga]Ga-PSMA-11 preparation using Locametz and Illuccix kits.

EJNMMI Radiopharm Chem. 2024-12-18

[4]
Advances in Radioligand Theranostics in Oncology.

Mol Diagn Ther. 2024-5

[5]
Optimization and scale up of production of the PSMA imaging agent [F]AlF-P16-093 on a custom automated radiosynthesis platform.

EJNMMI Radiopharm Chem. 2024-2-23

[6]
Fully automated radiosynthesis of [Ga]Ga-FAPI-46 with cyclotron produced gallium.

EJNMMI Radiopharm Chem. 2023-10-16

[7]
Cyclotron Production of Gallium-68 Radiopharmaceuticals Using the Zn(p,n)Ga Reaction and Their Regulatory Aspects.

Pharmaceutics. 2022-12-26

[8]
Recovery of Gallium-68 and Zinc from HNO-Based Solution by Liquid-Liquid Extraction with Arylamino Phosphonates.

Molecules. 2022-12-1

[9]
Preparation and Evaluation of [F]AlF-NOTA-NOC for PET Imaging of Neuroendocrine Tumors: Comparison to [Ga]Ga-DOTA/NOTA-NOC.

Molecules. 2022-10-12

[10]
Good practices for Ga radiopharmaceutical production.

EJNMMI Radiopharm Chem. 2022-10-22

本文引用的文献

[1]
Automated radiosynthesis of Ga for large-scale routine production using Zn pressed target.

Appl Radiat Isot. 2020-2

[2]
Taking cyclotron Ga production to the next level: Expeditious solid target production of Ga for preparation of radiotracers.

Nucl Med Biol. 2020

[3]
Production of radiometals in liquid targets.

EJNMMI Radiopharm Chem. 2020-1-10

[4]
Cyclotron production of Ga in a liquid target: Effects of solution composition and irradiation parameters.

Nucl Med Biol. 2019-4-15

[5]
Production of curie quantities of Ga with a medical cyclotron via the Zn(p,n)Ga reaction.

Appl Radiat Isot. 2018-3

[6]
A GALLIUM-68 POSITRON COW FOR MEDICAL USE.

J Nucl Med. 1964-6

[7]
A positron cow.

Int J Appl Radiat Isot. 1960-7

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