Validation of 68Ge/68Ga generator processing by chemical purification for routine clinical application of 68Ga-DOTATOC

Introduction: Imaging of somatostatin receptor expressing tumors has been greatly enhanced by the use of Ga-68-DOTATOC and PET/CT. Methods: In this work, a purification method for the Ge-68/Ge-68 generator eluate and a method to produce Ga-68-DOTATOC suitable for clinical use were evaluated. The generator eluate was purified and concentrated on a cation-exchange cartridge in HCl/acetone media. The efficacy of this procedure in eliminating metal impurities from the Ga-68 soultion was investigated by ICP-Ms. The radiotracer quality was evaluated by radio-TLC, and gamma-ray spectrometry. Resutls: Ga-68-DOTATOC preparations (n=33) were carried out with a mean synthesis yield of 59.3 +/- 2.8% (not corrected for decay) and a batch activity ranging from >95% of the Fe(III), Zn(II) and Mn(II) were eliminated from the solution. Conclusions: Ga-68-DOTATOC produced with this method can be efficiently used in nuclear medicine departments for PET evaluations. (C) 2008 Elsevier Inc. All rights reserved.