68Ga-Autoclabeling of DOTA-TATE and DOTA-NOC

Introduction: A new method combining Ga-68-labeling and steam sterilization, here called autoclabeling, has been evaluated for two somatostatin receptor binding tracers used for positron emission tomography (PET) imaging of neuroendocrine tumors; DOTA-TATE and -NOC. Methods: The two peptides DOTA-TATE and -NOC were labeled with Ga-68 by heating for 15 min at 121 degrees C in the presence of acetate buffer at pH 4.3. The product solutions were tested for sterility, presence of endotoxins, degradation of peptide and osmolality. Results: Complete incorporation of Ga-68 was obtained after the autoclabeling reaction and no degradation of the peptides was observed. Sterility was verified and the presence of endotoxins was well within Ph. Eur limits (175IU/maximum injected volume). Conclusions: The autoclabeling method provides a convenient procedure for Ga-68-labeling by combining the labeling reaction and steam sterilization into one single step. (c) 2012 Elsevier Ltd. All rights reserved.