Optimized production and quality control of super(68)Ga-EDTMP for small clinical trials

Objective: Optimized production and quality control of gallium-68 labeled ethylenediamine tetramethylene phosphonate ( super(68)Ga-EDTMP) as an efficient PET radiotracer for bone scans have been presented. Methods: Efforts have been made to present a fast, efficient, cost-effective and facile protocol for super(68)Ga-EDTMP productions for clinical trials. super(68)Ga-EDTMP was prepared using generator-based super(68)GaCl sub(3) 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 155 min. Results: super(68)Ga-EDTMP was prepared at optimized conditions in 5-10 min at 50-60 degree C (radiochemical purity approximately 99 plus or minus 0.88 % ITLC, >99 % HPLC, specific activity: 15-18 GBq/mM). The biodistribution of the tracer demonstrated high bone uptake of the tracer in 10-20 min while yielding the best images in 2 h. Conclusion: The whole production and quality control of super(68)Ga-EDTMP including labeling, purification, HPLC analysis, sterilization and LAL test took 18-20 min with significant specific activity for administration to limited number of patients in a PET center.