Validation of a new protocol for ¹⁸F-FDG infusion using an automatic combined dispenser and injector system.
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 (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.
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 (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.
RESULTS
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).
CONCLUSION
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.
Links
Authors
Lecchi M, Lucignani G, Maioli C, Ignelzi G, Del Sole A
Institution
Department of Health Sciences and Centre of Molecular and Cellular Imaging (IMAGO), University of Milan, Milan, Italy.
Source
European journal of nuclear medicine and molecular imaging 39:11 2012 Nov pg 1720-9Pub Type(s)
Journal ArticleResearch Support, Non-U.S. Gov't
Language
eng
PubMed ID
22740098
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