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首页> 外文期刊>EJNMMI Radiopharmacy and Chemistry >Multi-curie production of gallium-68 on a biomedical cyclotron and automated radiolabelling of PSMA-11 and DOTATATE
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Multi-curie production of gallium-68 on a biomedical cyclotron and automated radiolabelling of PSMA-11 and DOTATATE

机译：在生物医学回旋加速器上的镓-68的多居里生产和PSMA-11的自动放射性标记和致乳液

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Background With increasing clinical demand for gallium-68, commercial germanium-68/gallium-68 ([ 68 Ge]Ge/[ 68 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 [ 68 Ga]GaCl 3 from solid zinc-68 targets and subsequent labelling to produce clinical-grade [ 68 Ga]Ga-PSMA-11 and [ 68 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 [ 68 Ga]GaCl 3 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 [ 68 Ga]GaCl 3 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 [ 68 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 [ 68 Ga]GaCl 3 , 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 [ 68 Ga]GaCl 3 for radiolabelling and [ 68 Ga]Ga-PSMA-11 are promising for clinical use.
机译：背景技术随着临床需求增加镓-68，商业锗-68 /镓-68（[68 Ge] Ge / [68 Ga]发电机不能提供足够的短寿命的女儿同位素。在该研究中，我们证明了一种从固体锌-68靶标产生多居曲线水平的高产，自动化方法，并随后标记以产生临床级[68Ga] GA-PSMA-11和[68 ga] ga-dotatate。结果富含锌-68靶标在高达80μA的含有13℃的温度，120？min;在预期的纯化（EOP）结束时，反复产生高达194的GBQ（5.24·CI）纯化的镓-68的纯化的镓-68，从预期的纯化（EOP）的形式。？370？GBQ（＆？10 ？CI）在轰炸结束时。完全自动化的溶出/分离过程在35？min完成。根据pH值分析孤立的产品。欧元。 Initograph for Accelerator产生了[68 Ga] Gacl 3，发现符合所有规格。在各种情况下，放射化学纯度超过99.9％，重要的是，放射性核酸纯度足以允许基于该公制的保质期基于该度量。全自动生产高达72.2？GBQ [68Ga] GA-PSMA-11，提供高放射化学纯度（＆ 98.2％）和高达722 mbq / Nmol的非常高的表观摩尔活性的产品。此外，高达3.2的手动放射性标记为高产率（＆β95％），具有足以进行临床用途的表观摩尔活性（9-25〜MBQ / Nmol）。结论我们开发了一种高产，自动化方法，用于生产非常大量的[68Ga] GaCl 3，足以提供近端放射性神经活力。报告的方法导致历史新高纯净的镓-68活性（194〜GBQ在纯化结束时）和随后的PSMA-11标记和致乳腺酸盐。该方法高度自动从照射到产品的配制，并因此包括高水平的辐射保护。用于放射性标记的[68Ga] GaCl 3的质量控制结果和[68Ga] Ga-PSMA-11对临床使用有望。

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