Development and validation of a kit formulation of [68Ga]Ga-P15-041 as a bone imaging agent. (March 2021)

• Record Type: Journal Article
• Authors: Hong, Haiyan; Ploessl, Karl; Zha, Zhihao; Wang, Hui; Guo, Rui; Xie, Qing; Zhu, Hua; Yang, Zhi; Zhu, Lin; Kung, Hank F.
• Is Part Of: Applied radiation and isotopes. Volume 169(2021)
• Publication Date: 2021-03
• Subjects: Bone scan -- 68Ga -- [68Ga]Ga-HBED–CC–BP -- Lyophilized kit and [68Ga]Ga-P15-041; Radiology -- Periodicals; Radiation -- Industrial applications -- Periodicals; Nuclear chemistry -- Periodicals; Internet resource; Periodical; 660.298
• DOI: 10.1016/j.apradiso.2020.109485
• Languages: English
• ISSNs: 0969-8043

Abstract

Abstract: One of the commonly performed studies in nuclear medicine are bone scans with [ 99m Tc]Tc-methylene diphosphonate (MDP) for detecting various bone lesions, including cancer metastasis. The recent emergence of commercially available 68 Ge/ 68 Ga radionuclide generators makes it possible to provide 68 Ga-labelled bisphosphonates as positron emission tomography (PET) tracers for bone imaging. Preliminary human studies suggested that [ 68 Ga]Ga-HBED–CC–BP ([ 68 Ga]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 [ 68 Ga]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 [ 68 Ga]Ga-P15-041 can be prepared manually within minutes with an excellent purity (> 90%) and readily meet the dose release criteria. When [ 68 Ga]Ga-P15-041 was evaluated in a patient with cancer, the imaging agent clearly showed accumulations in multiple lesions. In conclusion, [ 68 Ga]Ga-P15-041, prepared by a lyophilized kit, might be an excellent bone imaging agent for widespread clinical application. Highlights: Simple and reliable lyophilized kit formulation for preparation of [ 68 Ga]Ga-P15-041. Production of clinical doses of [ 68 Ga]Ga-P15-041 with excellent radiochemical purity. Patient dose preparation using [ 68 Ga]GaCl3 eluent from commercial generator. Very brief hands-on operation reducing radiation exposure. Demonstration of clinical utility of [ 68 Ga]Ga-P15-041 in patients with bone metastasis.