Validation of an automated dose-dispensing system for 18F-FDG administrations and associated reduction in operator extremity dose

O'Doherty, James; Woods, E.; Modde, Lorenzo; Mackewn, Jane E.

doi:10.1097/mnm.0000000000000027

Cited by 8 publications

(10 citation statements)

References 12 publications

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“…The desired volume of 18 F-FDG dispensed by each device declines as a function of a higher radioactive concentration when extracted from multidose vials (13). Therefore, a dispensed volume below 0.5 mL conspicuously worsened the administration error of the AI-300, which was already overestimated compared with the other devices.…”

Section: Resultsmentioning

confidence: 99%

“…Further study is required to evaluate the radiation protection ability and operational aspects of automated infusion devices (4,7,12,13).…”

Section: Resultsmentioning

confidence: 99%

“…Although they found that variation in the accuracy of the 18 F-FDG radioactivity administered by the Intego was within 3% (12), the quantitative accuracy of a wide range of radioactive concentrations and dispensed volumes was not clear. The administration accuracy of automated infusion devices depends on the radioactive 18 F-FDG concentration and the dispensed volume of 18 F-FDG (13). Therefore, the administration accuracy of all automated infusion devices must be confirmed and calibrated at the location in which they are used.…”

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confidence: 99%

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Comparison of 3 Devices for Automated Infusion of Positron-Emitting Radiotracers

Miyaji

Miwa

Wagatsuma

et al. 2017

J. Nucl. Med. Technol.

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The administration accuracy and precision of an automated infusion device for positron-emitting radiotracers are directly associated with bias and variance in the SUVs of 18 F-FDG PET/CT. Therefore, the accuracy of such devices must be confirmed and calibrated at locations in which they are used. The present study aimed to validate the administration accuracy of 3 automated infusion devices for quantitative PET assessment. Methods: Temporal variations as well as variations in radioactive concentrations and dispensed volumes of 18 F-FDG were determined for the M-130, AI-300, and UG-05 automated infusion devices. The total-test dispensed volumes were 25, 20, and 18.5 mL, respectively. A reference value was generated by measuring amounts of radioactivity using a standard dose calibrator. Administration accuracy was validated according to the criteria of the Japanese Society of Nuclear Medicine. Results: The temporal variation in the M-130 and UG-05 for a specified 185 MBq was relatively stable, in the range of −1.60%-0.92% and 1.16%-5.35%, respectively, whereas that in the AI-300 was −0.55%-8.68%. For the M-130 and UG-05 devices, the difference between measured and reference value was in the range of −5%-5%. The values measured by the AI-300 deviated from the reference values by a maximum of 30%, which depends on radioactive concentration and dispensed volume of 18 F-FDG. Conclusion: The administration accuracy of the AI-300 varied considerably under different conditions, but a software update might somewhat improve this. Our findings indicate that dispensed volumes of 18 F-FDG should be carefully considered when the radioactive concentration is high. Administration accuracy should be regularly confirmed at each location to maintain the quality of quantitative PET assessment. The present study provides useful information about how to confirm the administration accuracy of automated infusion devices.

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Section: Resultsmentioning

confidence: 99%

“…Further study is required to evaluate the radiation protection ability and operational aspects of automated infusion devices (4,7,12,13).…”

Section: Resultsmentioning

confidence: 99%

mentioning

confidence: 99%

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Comparison of 3 Devices for Automated Infusion of Positron-Emitting Radiotracers

Miyaji

Miwa

Wagatsuma

et al. 2017

J. Nucl. Med. Technol.

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“…These systems have a built-in reservoir for storing FDG in a sterile and shielded way, contain a dose calibrator connected with the reservoir, and have a system of tubing and pumps that are able to deliver a requested amount of activity to a shielded syringe or device ready for injection into the patient. Data has shown that these systems are accurate, deliver activities for injection within a 3% margin of that requested, combined with reductions in the radiation exposure to the hands and fingers of technologists of 80-94% compared to manual dispensing and injection (32,33).…”

Section: Automated Dispensing and Injectionmentioning

confidence: 99%

Quality Assessment in FDG-PET/CT Imaging of Head-and-Neck Cancer: One Home Run Is Better Than Two Doubles

2020

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2-deoxy-2-[ 18 F]fluoro-D-glucose (FDG) positron emission tomography (PET)/computed tomography (CT) is indicated in head-and-neck cancer for the initial workup when clinically indicated (e. g., large tumors, clinically positive neck, cervical adenopathy from an unknown primary, etc.), for the assessment of treatment response 12 weeks after completion of (chemo)radiotherapy, and during follow-up when there is suspicion of relapse. The successful implementation of FDG-PET/CT in routine clinical practice requires an in-depth understanding of the recent advances in physics and engineering that have significantly improved the imaging capabilities of PET/CT scanners (e.g., digital silicon photomultipliers, point-spread function modeling, and time-of-flight, and Bayesian penalized likelihood reconstruction). Moreover, a coordinated harmonization effort from professional societies (e.g., EANM) and international bodies (e.g., IAEA) has resulted in the creation of quality assurance frameworks (e.g., QUANUM, EARL, GMP) and guidelines that collectively cover the entire spectrum from tracer production, hardware calibration, patient preparation, and scan acquisition, to image interpretation (e.g., PERCIST, Hopkins criteria). The ultimate goal is to standardize the PET/CT technique and to guarantee accurate and reproducible imaging results for every patient. This review summarizes the recent technical breakthroughs in PET/CT scan design and describes the existing quality assessment frameworks with a focus on applications in head-and-neck cancer. Strict adherence to these harmonization efforts will enable leveraging the full potential of PET/CT and translate the proven benefits of this technique into tangible improvements in outcome for patients with head-and-neck cancer in routine clinical care.

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“…Since many evidences showed substantial benefits in radioprotection for the operators in terms of dosimetry, many nuclear medicine departments have equipped themselves with automated dispensing systems (ADS) (Covens et al 2010). Most of the validations found in the literature consist in monitoring physico-medical parameters such as operator dosimetry and accuracy and/or precision of dose activities measurements through dose calibrators (Lecchi et al 2012;O'Doherty et al 2014). Whether partially or fully automated, to date there is no marketed ADS representing a true "closed-system".…”

Section: Introductionmentioning

confidence: 99%

Have you looked for “stranger things” in your automated PET dose dispensing system? A process and operators qualification scheme

Martin

Moyon

Fersing

et al. 2019

EJNMMI radiopharm. chem.

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Background: Many nuclear medicine departments have equipped themselves with automated dispensing systems (ADS) for PET radiopharmaceuticals, in both the operators' and the patients' interests. Whether partially or fully automated, to date there is no marketed ADS representing a true "closed-system". Despite the sterile, injectable nature of ready-to-use radiopharmaceutical drug solutions manipulated by these systems, neither manufacturer's recommendation nor literature report was found about specific qualification of the process' sterility, or about operators' qualification on these dispensing systems. We set up a master plan validation in a radiopharmacy equipped with Trasis Unidose®, including: 1) monthly processsimulating media-fill tests and microbiological contamination assessments of the ADS surfaces; 2) initial and periodic qualification of the operators. The microbiological qualification consisted in surface biocontamination assessment on critical zones with Tryptic-Soy agar. The operator qualification consisted in the evaluation of the operators' knowledge and skills for using the ADS. Results: This study highlighted a minor, handborne microbiological contamination on our first assessment, that corrective actions solved. We therefore decided to brief our operators once a month on microbiological control results, hygiene and good practices, with the support of the present case illustrating the biodecontamination efficiency. Conclusions: As the automation of PET monodose conditioning process still implies human intervention for material preparation and manual biodecontamination, this study illustrates that initial and periodic qualification of the environment and the conditioning process of ADS, including microbiological qualification and operators' qualification, are needed to meet specifications.

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Validation of an automated dose-dispensing system for 18F-FDG administrations and associated reduction in operator extremity dose

Abstract: The μDDS-A reproducibly partitions a vial of F-FDG and offers a significant reduction in extremity dose to the operator of up to 80% in comparison with a manual partition technique.

Cited by 8 publications

References 12 publications

Comparison of 3 Devices for Automated Infusion of Positron-Emitting Radiotracers

Comparison of 3 Devices for Automated Infusion of Positron-Emitting Radiotracers

Quality Assessment in FDG-PET/CT Imaging of Head-and-Neck Cancer: One Home Run Is Better Than Two Doubles

Have you looked for “stranger things” in your automated PET dose dispensing system? A process and operators qualification scheme

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