Critical aspects of <sup>68</sup>Ga production and chemistry in relation to clinical applications — ASN Events
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  3. Critical aspects of 68Ga production and chemistry in relation to clinical applications

Critical aspects of 68Ga production and chemistry in relation to clinical applications (#127)

Irina Velikyan 1
  1. PET-Centre, Uppsala University Hospital, Uppsala, Sweden

68Ga/PET-CT for targeted imaging has become an integrated function of theranostics and radiotheranostics, particularly in oncology. The application of 68Ga/PET-CT goes beyond accurate localization with high resolution and high lesion detection rate with precise staging. It allows quantitative diagnosis and personalized patient management. In this context the amount of the administered radiopharmaceutical, biology of the target and its interaction nature with the radiopharmaceutical are of outmost importance for the relevant 68Ga/PET-CT examination design and result interpretation. The radiopharmaceutical production and quality aspects influence the possibility and availability of such application. The binding site density and amount, ligand cost and side effects put restrictions and requirements to the 68Ga-radiopharmaceutical production and quality.

               Clinical studies in patients affected by neuroendocrine tumors and breast cancer using peptide-based 68Ga-radiopharmaceuticals clearly demonstrated the influence of the specific radioactivity of the radiopharmaceuticals ([68Ga]Ga-DOTATOC, [68Ga]Ga-DOTATATE, [68Ga]Ga-ABY-025)  on the organ distribution pattern and lesion detection rate. The tracer production methodology in its turn depends on the required specific radioactivity. The results of the studies stressed the importance of the personalized medicine approach in the diagnosis and treatment protocols as well as the relevant choice of the 68Ga-labelling methods.

               The requirements for the accurate control of the injected peptide mass also puts constraints on the radiopharmaceutical production and quality control. There are several basic production options available that allow choice of a method relevant to given quality requirements and logistics. Another critical aspect restricting the wide dissemination of 68Ga/PET is the current perception and interpretation of 68Ga-radiopharmaceutical manufacturing procedure from the good manufacturing practice (GMP) point of view. In particular the distinction between GMP manufacturing process and a preparation under pharmaceutical practice requires clarification in the case of 68Ga.