Experience in Production of 68Ga-DOTA-NOC for Clinical Use Under an Expanded Access IND

Abstract

[68Ga]Ga-DOTA-NOC was produced under an Expanded Access IND for 174 clinical PET/CT studies to evaluate patients with neuroendocrine tumors. Production employed either the TiO2-based Eckert & Ziegler (EZAG) 68Ge/68Ga-generator (with fractionated elution), or the SiO2-based ITG 68Ge/68Ga-generator. In both cases, [68Ga]Ga-DOTA-NOC was reliably produced, without pre-synthesis purification of the68Ga generator eluate, using readily-implemented manual synthesis procedures. [68Ga]Ga-DOTA-NOC radiochemical purity averaged 99.2±0.4%. Administered 68Ga dose averaged 181±22 MBq, and administered peptide mass averaged 43.2±5.2 µg (n=47) and 23.9±5.7 µg (n=127), respectively, using the EZAG and ITG generators. At dose expiration, 68Ge breakthrough in the final product averaged 2.7×10−7% and 5.4×10−5% using the EZAG and ITG generators, respectively.