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首页> 外文期刊>Cancer biotherapy and radiopharmaceuticals >Convenient Formulation of 68 Ga-BPAMD Patient Dose Using Lyophilized BPAMD Kit and 68 Ga Sourced from Different Commercial Generators for Imaging of Skeletal Metastases
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Convenient Formulation of 68 Ga-BPAMD Patient Dose Using Lyophilized BPAMD Kit and 68 Ga Sourced from Different Commercial Generators for Imaging of Skeletal Metastases

机译：使用冻干的BPAMD套件和来自不同商业发电机的68 Ga，从不同的商业发电机提供68A-BPAMD患者剂量的制剂，用于成像骨架转移

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Purpose: ~(68)Ga-BPAMD has recently emerged as one of the preferred radiopharmaceuticals for imaging of bone lesions due to its ability to produce high-resolution images and uncomplicated availability of ~(68)Ga, a positron emission tomography (PET) radionuclide, from commercial ~(68)Ge/~(68)Ga generators. The primary objective of this work is to develop freeze-dried BPAMD kit, for the easy and convenient formulation of ~(68)Ga-BPAMD patient dose at the hospital radiopharmacy. In addition, the kit should be compatible with ~(68)Ga, eluted using HCl of various molarities from the ~(68)Ge/~(68)Ga generators sourced from different suppliers. Procedures: Freeze-dried BPAMD kit, comprising 50 μg of BPAMD and 150 mg of HEPES, was prepared and evaluated using ~(68)Ga eluted from three different ~(68)Ge/~(68)Ga generators. Radiochemical purity (RCP) of ~(68)Ga-BPAMD was determined by both thin-layer chromatography and high-performance liquid chromatography studies. The maximum volume of ~(68)Ga, which can be added in the kit, was determined. The biological behavior of ~(68)Ga-BPAMD, prepared using the freeze-dried kit, was evaluated by both in vitro and in vivo studies. Clinical studies were also performed in limited number of patients suffering from metastatic bone cancer. Results: ~(68)Ga-BPAMD could be prepared with >95% RCP using the freeze-dried BPAMD kit and ~(68)Ga eluted from ~(68)Ge/~(68)Ga generators obtained from three different suppliers. ~(68)Ga-BPAMD, prepared using the freeze-dried kit, exhibited adequate serum stability and ～91% binding with the hydroxyapatite particles. Biodistribution studies in normal Wistar rats exhibited selective uptake of the agent in skeleton and fast clearance of the nonaccumulated activity through urinary route. Clinical studies in cancer patients showed excellent accumulation of the agent in bone lesions. Conclusion: The preliminary studies exhibited the potential of the developed BPAMD kit toward its utilization for the PET scanning of skeletal metastases.
机译：目的：〜（68）Ga-BPAMD最近被出现为骨病变成像的首选放射性药物之一，因为它产生高分辨率图像和简单的〜（68）Ga，正电子发射断层扫描（PET）放射性核素，来自商业〜（68）GE /〜（68）GA发电机。这项工作的主要目标是开发冻干BPAMD试剂盒，用于易于方便地制定〜（68）GA-BPAMD患者剂量在医院放射性药物。此外，该试剂盒应该与〜（68）Ga兼容，使用来自不同供应商的〜（68）Ge /〜（68）GA发电机的各种摩尔的HCl洗脱。使用三种不同〜（68）Ge /〜（68）GA发电机洗脱，制备包含50μgBPAMD和150mg HEPES的冻干BPAMD试剂盒，并使用〜（68）GA洗脱。通过薄层色谱和高性能液相色谱研究测定〜（68）Ga-BPAM的放射化学纯度（RCP）。确定可以在试剂盒中添加的〜（68）Ga的最大体积。使用冷冻干燥试剂盒制备的〜（68）Ga-BPAMD的生物学行为通过体外和体内研究评估。还在有限数量的患有转移性骨癌的患者中进行临床研究。结果：〜（68）GA-BPAMD可以使用> 95％RCP使用冻干BPAMD试剂盒和〜（68）GA从三种不同供应商获得的GA发电机洗脱的〜（68）GA。 〜（68）使用冷冻干燥试剂盒制备的GA-BPAMD表现出足够的血清稳定性和与羟基磷灰石颗粒的约束力〜91％。正常Wistar大鼠的生物分布研究表现出在骨架中的选择性摄取，通过泌尿途径快速清除不差不容的活性。癌症患者的临床研究表明骨病变中药剂的优异积累。结论：初步研究表明，发达的BPAMD试剂盒朝着骨骼转移的宠物扫描利用的潜力。

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