Optimized production and quality control of 68 Ga-EDTMP for small clinical trials
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ORIGINAL ARTICLE
Optimized production and quality control of for small clinical trials
68
Alireza Mirzaei1 • Amir R. Jalilian1 • Ali Badbarin1 • Mohammad Mazidi1 Fatemeh Mirshojaei1 • Parham Geramifar2 • Davood Beiki2
Ga-EDTMP
•
Received: 10 February 2015 / Accepted: 6 April 2015 Ó The Japanese Society of Nuclear Medicine 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 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. Keywords Ga-68 EDTMP Production Quality control Optimization & Amir R. Jalilian [email protected] 1
Nuclear Science and Technology Research Institute, Postal code: 141551339 Tehran, Iran
2
Research Center for Nuclear Medicine, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran
Introduction Due to the increasing rate of morality and mortality of malignant diseases and low access to radionuclide sources, developing generator-based PET radiopharmaceuticals are of great importance. Thus, the high costs of installation and running a cyclotron in every nuclear medicine center are of less concern especially for large countries. Many Ga-68 generators have been developed by the industries based on organic and inorganic solid phases [1–3]. Bone metastases are common in the progression of various tumors such as prostate, breast, and lung carcinoma; often entail an occurrence of progressive pain [4] and occur in many patients with solid malignant tumors [5]. The longer half-life and intensive radiation dose to the patients from F-18 sodium fluoride has led to develop Ga68-based bone radiopharmaceuticals including 68GaEDTMP [6, 7]. Interesting studies have been performed for the development of new phosphonate-based Ga-68 tracers for PET bone imaging [6] based on aliphatic and cyclic molecules. Recently, novel radiogallium-labeled bone imaging agents using oligo-aspartic moieties have been presented due to their high affinity for hydroxyapatite [7]. Another interesting research project has been initia
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