Feasibility and evaluation of automated methods for radiolabeling of radiopharmaceutical kits with gallium-68.

OBJECTIVE: Recent gallium-68 labeled peptides are of increasing interest for 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 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®. Overtime, 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. Overcosts 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 was 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.