Literature DB >> 25903357

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

Alireza Mirzaei1, Amir R Jalilian, Ali Badbarin, Mohammad Mazidi, Fatemeh Mirshojaei, Parham Geramifar, Davood Beiki.   

Abstract

OBJECTIVE: 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.
METHODS: 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 155 min.
RESULTS: (68)Ga-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 (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.

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Year:  2015        PMID: 25903357     DOI: 10.1007/s12149-015-0971-9

Source DB:  PubMed          Journal:  Ann Nucl Med        ISSN: 0914-7187            Impact factor:   2.668


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