Optimized Production and Quality Control of 68Ga-Edtmp for Small Clinical Trials Publisher Pubmed



Mirzaei A¹ ; Jalilian AR¹ ; Badbarin A¹ ; Mazidi M¹ ; Mirshojaei F¹ ; Geramifar P² ; Beiki D² Show Affiliations
Source: Annals of Nuclear Medicine Published:2015

Abstract

Objective: Optimized production and quality control of gallium-68 labeled ethylenediamine tetramethylene phosphonate (68Ga-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 68Ga-EDTMP productions for clinical trials. 68Ga-EDTMP was prepared using generator-based 68GaCl3 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: 68Ga-EDTMP was prepared at optimized conditions in 5–10 min at 50–60 °C (radiochemical purity ≈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. Conclusion: The whole production and quality control of 68Ga-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. © 2015, The Japanese Society of Nuclear Medicine.