Alagona P, Hart D T, Eikman E A
St. Joseph's Positron Center, Medical Divison, Tampa, FL 33607-4227.
Int J Card Imaging. 1994 Jun;10(2):137-43. doi: 10.1007/BF01137709.
Radiopharmaceutical availability is one of the reasons dissemination and growth of clinical PET imaging remains problematic. A 'regional' cyclotron-radiopharmacy facility for the production of the positron emitting radionuclide 2-deoxy-2[18F]-fluoro-D-glucose (FDG), has been operational for over 2 years and supplies this radiopharmaceutical to five camera facilities, four distant and one on-site. The RDS 11 MeV cyclotron is capable of dual bombardment of targets yielding 60 GBq (1600 mCi) of F-18 in a 90 minute period. F-18 labelled FDG is produced by an automated synthesis module yielding 22.2 GBq (600 mCi) FDG. The PET radiopharmacy is required to perform extensive quality assurance activities including a number of tests to insure final product and safety. [18F]FDG is shipped in unit dose vials, 6 ml, two per shielded container, meeting Department of Transportation (DOT) specifications (43 x 43 cm cubes, styrofoam packing, 22 lb. lead shield). This adheres to regulations requiring no more than 200 millirem per hour (mR/Hr) exposure at the container surface, and 10 mR/hr at a distance of 1 meter. Total transport time, utilizing private air and ground couriers, to distant facilities is approximately 100-120 minutes. Based on patient scheduling and protocol used, allowing 45-60 minutes between dose administrations, and availability of 22.2 GBq (600 mCi), 20-22 unit doses can be supplied, divided and shipped in a number of ways. The regional-commercial distribution of PET radiopharmaceuticals, specifically [18F]FDG, is feasible. This provides availability of metabolic imaging at sites distant to radiopharmaceutical production.
放射性药物的可获得性是临床正电子发射断层显像（PET）成像的传播和发展仍然存在问题的原因之一。一家用于生产正电子发射放射性核素2-脱氧-2-[18F]-氟-D-葡萄糖（FDG）的“区域”回旋加速器-放射性药物设施已经运行了两年多，并向五个显像设备供应这种放射性药物，其中四个在远处，一个在现场。RDS 11 MeV回旋加速器能够对靶材进行双重轰击，在90分钟内产生60 GBq（1600 mCi）的F-18。F-18标记的FDG由一个自动合成模块生产，产量为22.2 GBq（600 mCi）。PET放射性药物药房需要开展广泛的质量保证活动，包括多项测试以确保最终产品质量和安全性。[18F]FDG以单剂量小瓶包装运输，每瓶6 ml，每个屏蔽容器装两瓶，符合美国运输部（DOT）的规范（43×43 cm立方体，泡沫塑料包装，22磅铅屏蔽）。这符合相关规定，即容器表面的辐射暴露不超过每小时200毫雷姆（mR/Hr），在1米距离处为10 mR/hr。利用私人航空和地面快递将药物运送到远处设施的总运输时间约为100 - 120分钟。根据患者的日程安排和所用方案，给药间隔为45 - 60分钟，且有22.2 GBq（600 mCi）的可用剂量，可提供20 - 22个单剂量，并能以多种方式进行分装和运输。PET放射性药物，特别是[18F]FDG的区域 - 商业配送是可行的。这使得在远离放射性药物生产地点的地方也能进行代谢成像检查。
