Browsing by Subject "expanded access IND"

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    Experience in Production of 68Ga-DOTA-NOC for Clinical Use Under an Expanded Access IND
    (Elsevier, 2016-10) Green, Mark A.; Mathias, Carla J.; Fletcher, James W.; Department of Radiology and Imaging Sciences, IU School of Medicine
    [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.