Validation of (68)Ge/(68)Ga generator processing by chemical purification for routine clinical application of (68)Ga-DOTATOC

Nucl Med Biol. 2008 Aug;35(6):721-4. doi: 10.1016/j.nucmedbio.2008.04.006. Epub 2008 Jun 17.

Abstract

Introduction: 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.

Publication types

  • Validation Study

MeSH terms

  • Clinical Medicine / methods
  • Gallium Radioisotopes / chemistry*
  • Isotope Labeling / methods
  • Octreotide / analogs & derivatives*
  • Octreotide / chemical synthesis
  • Organometallic Compounds / chemical synthesis*
  • Positron-Emission Tomography / methods*
  • Radiopharmaceuticals / chemistry*

Substances

  • Ga(III)-DOTATOC
  • Gallium Radioisotopes
  • Organometallic Compounds
  • Radiopharmaceuticals
  • Octreotide