title: Experience in production of (68)Ga-DOTA-NOC for clinical use under an Expanded Access IND.
abstract: [(68)Ga]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) (68)Ge/(68)Ga-generator (with fractionated elution), or the SiO2-based ITG (68)Ge/(68)Ga-generator. In both cases, [(68)Ga]Ga-DOTA-NOC was reliably produced, without pre-synthesis purification of the(68)Ga generator eluate, using readily-implemented manual synthesis procedures. [(68)Ga]Ga-DOTA-NOC radiochemical purity averaged 99.2±0.4%. Administered (68)Ga dose averaged 181±22 MBq, and administered peptide mass averaged 43.2±5.2µg (n=47) and 23.9±5.7µg (n=127), respectively, using the EZAG and ITG generators. At dose expiration, (68)Ge breakthrough in the final product averaged 2.7×10(-7)% and 5.4×10(-5%) using the EZAG and ITG generators, respectively.
authors: Department of Radiology and Imaging Sciences, Indiana University School of Medicine, Indianapolis, IN, 46202 United States. Electronic address: magreen@iu.edu.
authors: Mark A
authors: MA
authors: Green
authors: Department of Radiology and Imaging Sciences, Indiana University School of Medicine, Indianapolis, IN, 46202 United States.
authors: Carla J
authors: CJ
authors: Mathias
authors: Department of Radiology and Imaging Sciences, Indiana University School of Medicine, Indianapolis, IN, 46202 United States.
authors: James W
authors: JW
authors: Fletcher
keywords: Expanded Access IND; Neuroendrocrine tumors; Positron emission tomography (PET); Somatostatin receptor; [68Ga]Ga-DOTA-NOC