Department of Health Sciences and Centre of Molecular and Cellular Imaging (IMAGO), University of Milan, Milan, Italy.
Eur J Nucl Med Mol Imaging. 2012 Nov;39(11):1720-9. doi: 10.1007/s00259-012-2174-0. Epub 2012 Jun 28.
In nuclear medicine, radiopharmaceuticals are usually administered in unit doses partitioned from multi-dose vials. The partitioning typically takes place in a radiopharmacy, depending on local practice. Automatic, as opposed to manual, partitioning and administration should reduce radiation exposure of the personnel involved, improve the accuracy of the administration and mitigate contamination. This study set out to verify and validate the (18)F-fluorodeoxyglucose (FDG) administration procedure performed using Intego (MEDRAD, Inc., Warrendale, PA, USA), a combined dispenser and injector system. We considered maintenance of sterility and the system's potential to improve, with respect to the manual procedure, the accuracy of net administered (18)F-FDG radioactivity in patients and the radiation protection of operators.
A media-fill procedure was used to assess whether sterility is maintained during use of the Intego system. Simulating a typical working day's setup and use of the system, we investigated the accuracy of the net administered (18)F-FDG activity obtained with Intego versus the manual dose delivery system. We also measured personnel radiation exposure during use of Intego and during manual administration and recorded and compared environmental doses in the two conditions.
The radiopharmaceutical remained sterile in all the tests performed. The accuracy of the net (18)F-FDG activity delivered to the patients was found to be within 3 % points, as required by European Association of Nuclear Medicine (EANM) guidelines on (18)F-FDG imaging procedures. With Intego, the residual radioactivity in the tubing was 0.20 MBq, corresponding to approximately 0.07 % of the mean activity delivered. With manual injection, the residual radioactivity in the syringe averaged 7.37 MBq, corresponding to a mean error of 2.9 % in the delivered dose. During the injection step of the positron emission tomography (PET) procedure, whole-body and extremity radiation exposures were significantly reduced with Intego by 38 and by 94 %, respectively, compared to the levels associated with manual administration (p < 0.05).
Integoaccurately partitions and administers sterile doses of (18)F-FDG from multi-dose vials. Compared with standard manual (18)F-FDG administration, the new procedure with an automatic dispensing and injection system greatly reduces the extremity dose to the operator involved in the administration of the radiopharmaceutical.
在核医学中，放射性药物通常以单位剂量从多剂量小瓶中分配。这种分配通常在放射性药物配制室进行，具体取决于当地的实践情况。与手动分配相比，自动分配和给药应能降低相关人员的辐射暴露，提高给药的准确性，并减轻污染。本研究旨在验证和验证使用 Intego（MEDRAD，Inc.，宾夕法尼亚州 Warrendale）进行的（18）F-氟脱氧葡萄糖（FDG）给药程序，这是一种结合分配器和注射器系统。我们考虑了保持无菌性以及该系统相对于手动程序提高患者接受的净（18）F-FDG 放射性活性的准确性和操作人员的辐射防护能力。
采用介质填充程序来评估 Intego 系统在使用过程中是否保持无菌性。模拟典型工作日的设置和系统使用情况，我们研究了 Intego 与手动剂量输送系统相比获得的净（18）F-FDG 活性的准确性。我们还测量了 Intego 使用期间和手动给药期间的人员辐射暴露，并记录和比较了两种情况下的环境剂量。
在所有进行的测试中，放射性药物均保持无菌。结果发现，根据欧洲核医学协会（EANM）关于（18）F-FDG 成像程序的指南，患者接受的净（18）F-FDG 活性的准确性在 3%以内。使用 Intego，管内残留放射性活度为 0.20MBq，相当于输送平均活度的 0.07%。使用手动注射时，注射器内残留放射性活度平均为 7.37MBq，相当于输送剂量的平均误差为 2.9%。与手动给药相比，在正电子发射断层扫描（PET）程序的注射步骤中，Intego 使全身和四肢的辐射暴露分别显著降低了 38%和 94%（p<0.05）。
Intego 可以从多剂量小瓶中准确地分配和给予无菌剂量的（18）F-FDG。与标准手动（18）F-FDG 给药相比，新的自动分配和注射系统大大降低了给药过程中涉及的操作人员的四肢剂量。
