Abstract
Optimized production and quality control of gallium-68 labeled ethylenediamine tetramethylene phosphonate ((68)Ga-EDTMP) as an efficient PET radiotracer for bone scans have been presented. Efforts have been made to present a fast, efficient, cost-effective and facile protocol for (68)Ga-EDTMP productions for clinical trials. (68)Ga-EDTMP was prepared using generator-based (68)GaCl3 and EDTMP at optimized conditions for time, temperature, ligand amount, gallium content followed by proper formulation. The biodistribution of the tracer in rats was studied using tissue counting and PET/CT imaging up to 155min. (68)Ga-EDTMP was prepared at optimized conditions in 5-10min at 50-60°C (radiochemical purity ≈99±0.88% ITLC, >99% HPLC, specific activity: 15-18GBq/mM). The biodistribution of the tracer demonstrated high bone uptake of the tracer in 10-20min while yielding the best images in 2h. The whole production and quality control of (68)Ga-EDTMP including labeling, purification, HPLC analysis, sterilization and LAL test took 18-20min with significant specific activity for administration to limited number of patients in a PET center.
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