Title:Feasibility and Evaluation of Automated Methods for Radiolabeling of Radiopharmaceutical Kits with Gallium-68
Volume: 12
Issue: 3
Author(s): Alban Revy, François Hallouard*, Sandrine Joyeux-Klamber, Andrea Skanjeti, Catherine Rioufol and Marc Fraysse
Affiliation:
- Hospices Civils de Lyon, Centre Hospitalier de Lyon Sud, Service de Pharmacie, unite de radiopharmacie, 165 Chemin du Grand Revoyet F-69310 Pierre-Benite,France
Keywords:
Gallium-68, positron-emission tomography radiolabeling, radiopharmaceuticals kit, automatisation, preparation,
radiolabeling.
Abstract:
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.
