title: Optimized production and quality control of (68)Ga-EDTMP for small clinical trials.
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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Nuclear Science and Technology Research Institute, Postal code: 141551339, Tehran, Iran.
authors.forename: Alireza
authors.initials: A
authors.lastname: Mirzaei
authors.forename: Amir R
authors.initials: AR
authors.lastname: Jalilian
authors.forename: Ali
authors.initials: A
authors.lastname: Badbarin
authors.forename: Mohammad
authors.initials: M
authors.lastname: Mazidi
authors.forename: Fatemeh
authors.initials: F
authors.lastname: Mirshojaei
authors.forename: Parham
authors.initials: P
authors.lastname: Geramifar
authors.forename: Davood
authors.initials: D
authors.lastname: Beiki
mesh_terms: D000818:Animals; D001842:Bone and Bones / Q000000981:diagnostic imaging; D002845:Chromatography; D002851:Chromatography, High Pressure Liquid; D002986:Clinical Trials as Topic; D005710:Gallium Radioisotopes; D008297:Male; D015394:Molecular Structure; D064847:Multimodal Imaging; D009943:Organophosphorus Compounds / Q000138:chemical synthesis* / Q000302:isolation & purification; D049268:Positron-Emission Tomography / Q000379:methods; D011786:Quality Control; D019275:Radiopharmaceuticals / Q000138:chemical synthesis* / Q000302:isolation & purification; D051381:Rats; D013696:Temperature; D013997:Time Factors; D014057:Tomography, X-Ray Computed
chemical_list: D005710:Gallium Radioisotopes; D009943:Organophosphorus Compounds; D019275:Radiopharmaceuticals; C018940:(ethylenedinitrilo)-tetramethylenephosphonic acid