Published in:
01-11-2012 | Original Article
Validation of a new protocol for 18F-FDG infusion using an automatic combined dispenser and injector system
Authors:
Michela Lecchi, Giovanni Lucignani, Claudio Maioli, Giuseppe Ignelzi, Angelo Del Sole
Published in:
European Journal of Nuclear Medicine and Molecular Imaging
|
Issue 11/2012
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Abstract
Purpose
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 18F-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 18F-FDG radioactivity in patients and the radiation protection of operators.
Methods
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 18F-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.
Results
The radiopharmaceutical remained sterile in all the tests performed. The accuracy of the net 18F-FDG activity delivered to the patients was found to be within 3 % points, as required by European Association of Nuclear Medicine (EANM) guidelines on 18F-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).
Conclusion
Intego™accurately partitions and administers sterile doses of 18F-FDG from multi-dose vials. Compared with standard manual 18F-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.