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

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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.

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Authors and Affiliations

  1. Nuclear Science and Technology Research Institute, Postal code: 141551339, Tehran, Iran

    Alireza Mirzaei, Amir R. Jalilian, Ali Badbarin, Mohammad Mazidi & Fatemeh Mirshojaei

  2. Research Center for Nuclear Medicine, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran

    Parham Geramifar & Davood Beiki

Authors
  1. Alireza Mirzaei
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  2. Amir R. Jalilian
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  3. Ali Badbarin
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  4. Mohammad Mazidi
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  5. Fatemeh Mirshojaei
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  6. Parham Geramifar
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  7. Davood Beiki
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Correspondence to Amir R. Jalilian.

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Mirzaei, A., Jalilian, A.R., Badbarin, A. et al. Optimized production and quality control of 68Ga-EDTMP for small clinical trials. Ann Nucl Med 29, 506–511 (2015). https://doi.org/10.1007/s12149-015-0971-9

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  • DOI: https://doi.org/10.1007/s12149-015-0971-9

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