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Description
The application of 68Ga –labeled peptide for tumor diagnosis is growing very fast in the recent years. One of the traced peptide for tumor diagnosis in nuclear medicine is [68Ga]GaDOTA-TOC. The aim of the work was GMP preparation of [68Ga]GaDOTA-TOC for application in nuclear medicine for a routine diagnosis using automated production with TRACERlab® MX module and quality control according to the standards of European Pharmacopoeia. 68Ga for peptide tracing was obtained from 68Ge/68Ga generator iThemba Labs with initial activity 1850 MBq. 5 mL of 0.6 M HCl elution solution from the generator was collected to the vial and for synthesis of 68Ga labeled peptide a commercial cassette and chemical kit from ABX was used. 68Ga was collected on PS-H+ cartridge, washed and transferred to reaction vials with 5 M NaCl in which 50 µg of DOTA-TOC dissolved in 1.5 M HEPES was prepared. The temperature in the reactor vessels was kept 6 min at 125oC. The solution with reaction mixture was past trough a pre-conditioned Light C18 column and washed with water. Labeled [68Ga]GaDOTA-TOC was eluted with a mixture 1:1 ethanol/water to the vial and diluted with PBS buffer. Prepared solution was transferred to a dispense chamber trough a sterile filter. Decay correcting yield was about 89%. Parameters for quality control (QC) were appearance, pH, radionuclide purity, radionuclide identity, radiochemical purity, HEPES concentration, microbiological quality, bacterial endotoxins and ethanol concentration. All validation parameters of [68Ga]GaDOTA-TOC QC analysis prepared were fulfilled. Radiochemical purity was better than 98.8%. 68Ga impurity in colloidal form was less than 1% and free 68Ga3+ was less than 0.1%. Prepared [68Ga]GaDOTA-TOC was used in patients with neuroendocrine tumours (NET) with better sensitivity and spatial resolution in comparison to standard imaging procedure.