One of the commonly performed studies in nuclear medicine are bone scans with [^99mTc]Tc-methylene diphosphonate (MDP) for detecting various bone lesions, including cancer metastasis. The recent emergence of commercially available ⁶⁸Ge/⁶⁸Ga radionuclide generators makes it possible to provide ⁶⁸Ga-labelled bisphosphonates as positron emission tomography (PET) tracers for bone imaging. Preliminary human studies suggested that [⁶⁸Ga]Ga-HBED–CC–BP ([⁶⁸Ga]Ga-P15-041) in conjunction with PET/computed tomography (CT) showed accumulation in known bone lesions, fast clearance from blood and soft tissue, and an ability to provide high contrast images. A simple and efficient lyophilized P15-041 kit formulation for the rapid production of [⁶⁸Ga]Ga-P15-041 with excellent radiochemical purity (RCP) under ambient temperature without the need for purification is described. It is demonstrated that clinical doses of [⁶⁸Ga]Ga-P15-041 can be prepared manually within minutes with an excellent purity (> 90%) and readily meet the dose release criteria. When [⁶⁸Ga]Ga-P15-041 was evaluated in a patient with cancer, the imaging agent clearly showed accumulations in multiple lesions. In conclusion, [⁶⁸Ga]Ga-P15-041, prepared by a lyophilized kit, might be an excellent bone imaging agent for widespread clinical application.

核医学中常用的研究之一是使用 [ ^99m Tc] Tc-亚甲基二膦酸盐 (MDP) 进行骨扫描，用于检测各种骨病变，包括癌症转移。最近出现的市售⁶⁸ Ge/ ⁶⁸ Ga 放射性核素发生器使得提供⁶⁸ Ga 标记的双膦酸盐作为骨成像的正电子发射断层扫描 (PET) 示踪剂成为可能。初步的人体研究表明 [ ⁶⁸ Ga]Ga-HBED-CC-BP（[ ⁶⁸Ga]Ga-P15-041) 与 PET/计算机断层扫描 (CT) 结合显示在已知骨病变中的积累，从血液和软组织中快速清除，以及提供高对比度图像的能力。描述了一种简单高效的冻干 P15-041 试剂盒配方，用于在环境温度下快速生产具有优异放射化学纯度 (RCP)的 [ ⁶⁸ Ga] Ga-P15-041，无需纯化。结果表明，临床剂量的 [ ⁶⁸ Ga] Ga-P15-041 可以在几分钟内以极好的纯度 (> 90%) 手动制备，并且很容易满足剂量释放标准。当在癌症患者中评估[ ⁶⁸ Ga]Ga-P15-041 时，显像剂清楚地显示出在多个病变中的积聚。总之，[ ⁶⁸Ga]Ga-P15-041，由冻干试剂盒制备，可能是一种广泛临床应用的优秀骨显像剂。