title: Validation of (68)Ge/(68)Ga generator processing by chemical purification for routine clinical application of (68)Ga-DOTATOC.
abstract: BACKGROUND
  Imaging of somatostatin receptor expressing tumours has been greatly enhanced by the use of (68)Ga-DOTATOC and PET/CT.
  
  
  METHODS
  In this work, a purification method for the (68)Ge/(68)Ga generator eluate and a method to produce (68)Ga-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 (68)Ga solution was investigated by ICP-MS. The radiotracer quality was evaluated by radio-TLC, GC and gamma-ray spectrometry.
  
  
  RESULTS
  (68)Ga-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 555 to 296 MBq. The radiochemical and radionuclidic purity were >98% and 99.9999%, respectively. With this purification process, >95% of the Fe(III), Zn(II) and Mn(II) were eliminated from the solution.
  
  
  CONCLUSIONS
  (68)Ga-DOTATOC produced with this method can be efficiently used in nuclear medicine departments for PET evaluations.
authors.affiliation: Nuclear Medicine Department, Santa Maria Nuova Hospital, Reggio Emilia, Italy. asti.mattia@asmn.re.it
authors.forename: Mattia
authors.initials: M
authors.lastname: Asti
authors.forename: Giovanni
authors.initials: G
authors.lastname: De Pietri
authors.forename: Alessandro
authors.initials: A
authors.lastname: Fraternali
authors.forename: Elisa
authors.initials: E
authors.lastname: Grassi
authors.forename: Roberto
authors.initials: R
authors.lastname: Sghedoni
authors.forename: Federica
authors.initials: F
authors.lastname: Fioroni
authors.forename: Frank
authors.initials: F
authors.lastname: Roesch
authors.forename: Annibale
authors.initials: A
authors.lastname: Versari
authors.forename: Diana
authors.initials: D
authors.lastname: Salvo
mesh_terms: D015510:Clinical Medicine / Q000379:methods; D005710:Gallium Radioisotopes / Q000737:chemistry*; D007553:Isotope Labeling / Q000379:methods; D015282:Octreotide / Q000031:analogs & derivatives* / Q000138:chemical synthesis; D009942:Organometallic Compounds / Q000138:chemical synthesis*; D049268:Positron-Emission Tomography / Q000379:methods*; D019275:Radiopharmaceuticals / Q000737:chemistry*
chemical_list: C499142:Ga(III)-DOTATOC; D005710:Gallium Radioisotopes; D009942:Organometallic Compounds; D019275:Radiopharmaceuticals; D015282:Octreotide