Automated radiosynthesis of GMP quality [18F]HX4 for PET imaging of hypoxia.

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ID: 2993
2015
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Abstract
[(18)F]HX4 is a 2-nitroimidazole based investigational radiotracer for imaging hypoxia.A two-step, one-pot synthetic procedure was developed on a GE Tracerlab MX-FDG with a disposable cassette. Nucleophilic substitution of a nosylate group with [(18)F]fluoride was followed by solvent evaporation and acidic removal of the acetyl protecting group. HPLC purification in a bio-compatible solvent mixture was developed.Using starting activities of 80-110 GBq [(18)F]fluoride, GMP compliant [(18)F]HX4 was produced in non-decay corrected radiochemical yields of 12 ± 3% (n = 9) in 55 min including HPLC purification. No reformulation steps were required. The mean specific activity of the final product was 2450 GBq/μmol. Modifications to the process and final formulation were included to prevent decomposition of the product, and these changes resulted in an improved stability of the formulated [(18)F]HX4, with a shelf-life of at least 8h post-synthesis. The product consistently passed all required quality control tests to determine that the [(18)F]HX4 was suitable for clinical use. Using a 90 minute target bombardment, and 80-110 GBq starting [(18)F]fluoride, the method produced multiple patient doses.
Reference Key
turton2015automatednuclear Use this key to autocite in the manuscript while using SciMatic Manuscript Manager or Thesis Manager
Authors Turton, David R;Betts, Helen M;Dutton, David;Perkins, Alan C;
Journal nuclear medicine and biology
Year 2015
DOI
S0969-8051(14)00583-6
URL
Keywords Keywords not found

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