Search

Objectives: Recent gallium-68 labeled peptides are of increasing interest in PET imaging in nuclear medicine. Somakit TOC® is a radiopharmaceutical kit registered in the European Union for the preparation of [68Ga]Ga-DOTA-TOC used for the diagnosis of neuroendocrine tumors. Development of a labeling process using a synthesizer is particularly interesting for the quality and reproducibility of the final product although only manual processes are described in the Summary of Product (SmPC) of the registered product. The aim of the present study was therefore to evaluate the feasibility and value of using an automated synthesizer for the preparation of [68Ga]Ga-DOTA-TOC according to the SmPC of the Somakit TOC®. Methods: Three methods of preparation were compared; each followed the SmPC of the Somakit TOC®. Over time, overheads, and overexposure were evaluated for each method. Results: Mean±SD preparation time was 26.2±0.3 minutes for the manual method, 28±0.5 minutes for the semi-automated, and 40.3±0.2 minutes for the automated method. Overcost of the semi-automated method is 0.25€ per preparation for consumables and from 0.58€ to 0.92€ for personnel costs according to the operator (respectively, technician or pharmacist). For the automated method, overcost is 70€ for consumables and from 4.06€ to 6.44€ for personnel. For the manual method, extremity exposure was 0.425mSv for the right finger, and 0.350mSv for the left finger; for both the semi-automated and automated method extremity exposure were below the limit of quantification. Conclusion: The present study reports for the first time both the feasibility of using a [68Ga]- radiopharmaceutical kit with a synthesizer and the limits for the development of a fully automated process.

Supplemental Digital Content is available in the text.Fractionated elution consists in collecting the fractions of an eluate with the highest radioactive concentration. It may be useful to meet the requirements of a subset of clinical radiopharmacy procedures. This study aims to describe and evaluate straightforward procedures allowing to readily perform fractionated elution on dry and wet columns 99Mo/99mTc generators by using calibrated vials. The main objectives of this study consisted in determining the relationship between eluate volume and elution yield using different vials calibration and assessing repeatability of the procedure. Elution vials were calibrated to obtain different eluate volumes by addition of air for wet column generator (WCG) and subtraction of saline for dry column generator (DCG) (n≥5 for each calibration). The relationship between the eluate volume and the elution yield was determined by a regression model for both DCG and WCG. Then repeatability evaluation was performed using 3-ml vial calibration. Relationships between the eluate volume (V) and the elution yield (Y) for DCG and WCG were Y=57.551 ln(V)+10.526 and Y=50.256 ln(V)+17.597, respectively. For repeatability assessment (n=30 for DCG and n=31 for WCG), the median volume and the interquartile range for DCG and WCG were 2.98 ml (2.92–3.01) and 3.28 ml (2.71–3.40), respectively, and median (interquartile range) eluate yields were 84.73% (81.30–86.33) and 81.78% (78.91–85.20), respectively. The volume was significantly higher for WCG than DCG (P=0.036) and also significantly more variable (P<0.001). The elution yield was significantly lower for WCG than DCG (P=0.025), but no difference in variability between the two generators was found (P=0.874). Easy-to-handle fractionated elution methods are compatible with both DCG and WCG. Fractionation using calibrated vials exhibits a better reproducibility with DCG than WCG generators and represents the only proposed method so far to master fractionated elution with DCG.

The aim of this study was to describe and evaluate an approach for improving radiopharmaceutical supply chain safety by implementing bar code technology. We first evaluated the current situation of our radiopharmaceutical supply chain and, by means of the ALARM protocol, analysed two dispensing errors that occurred in our department. Thereafter, we implemented a bar code system to secure selected key stages of the radiopharmaceutical supply chain. Finally, we evaluated the cost of this implementation, from overtime, to overheads, to additional radiation exposure to workers. An analysis of the events that occurred revealed a lack of identification of prepared or dispensed drugs. Moreover, the evaluation of the current radiopharmaceutical supply chain showed that the dispensation and injection steps needed to be further secured. The bar code system was used to reinforce product identification at three selected key stages: at usable stock entry; at preparation–dispensation; and during administration, allowing to check conformity between the labelling of the delivered product (identity and activity) and the prescription. The extra time needed for all these steps had no impact on the number and successful conduct of examinations. The investment cost was reduced (2600 euros for new material and 30 euros a year for additional supplies) because of pre-existing computing equipment. With regard to the radiation exposure to workers there was an insignificant overexposure for hands with this new organization because of the labelling and scanning processes of radiolabelled preparation vials. Implementation of bar code technology is now an essential part of a global securing approach towards optimum patient management.