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Lung PET/CT is a promising imaging modality for regional lung function assessment. Our aim was to develop and validate a fast, simple, and fully automated GMP compliant [ 68 Ga]Ga-MAA labeling procedure, using a commercially available [ 99m Tc]Tc-MAA kit, a direct gallium-68 eluate and including a purification of the [ 68 Ga]Ga-MAA.   Method:  The synthesis parameters (pH, heating temperature) were manually determined. Automated  68 Ga-labeling of MAA was then developed on a miniAIO (Trasis®, Ans, Belgium) module. An innovative automated process was developed for the purification. The process was then optimized and adapted to automate both the [ 68 Ga]Ga-MAA synthesis and the isolation of gallium-68 eluate required for the pulmonary ventilation PET/CT.   Results:  The 15-min process demonstrated high reliability and reproducibility, with high synthesis yield (&amp;gt;95 %). Mean [ 68 Ga]Ga-MAA radiochemical purity was 99 % ± 0.6 %. The  68 Ga-labeled MAA particles size and morphology remained unchanged.   Conclusion:  A fast, user friendly, and fully automated process to produce GMP [ 68 Ga]Ga-MAA for clinical use was developed. This automated process combining the advantages of using a non-modified MAA commercial kit, a gallium-68 eluate without pre-purification and an efficient final purification of the [ 68 Ga]Ga-MAA may facilitate the implementation of lung PET/CT imaging in nuclear medicine departments.

Fully Automated 68Ga-Labeling and Purification of Macroaggregated Albumin Particles for Lung Perfusion PET Imaging