Optimized production and quality control of ^sup 68^Ga-EDTMP for small clinical trials

Optimized production and quality control of gallium-68 labeled ethylenediamine tetramethylene phosphonate (^sup 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 ^sup 68^Ga-EDTMP productions for clinical trials. ^sup 68^Ga-EDTMP was prepared using generator-based ^sup 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. ^sup 68^Ga-EDTMP was prepared at optimized conditions in 5-10 min at 50-60 °C (radiochemical purity [asymptotically =]99 ± 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. The whole production and quality control of ^sup 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.