title: Preparation of [(68)Ga]PSMA-11 for PET-CT imaging using a manual synthesis module and organic matrix based (68)Ge/(68)Ga generator.
abstract: [(68)Ga]PSMA-11 is a relatively recently introduced radiopharmaceutical for PET-CT imaging of prostate cancer patients. The availability of (68)Ge/(68)Ga generator and PSMA-11 ligand from commercial sources is facilitating the production of the radiopharmaceutical in-house. This paper describes our experience on the preparation of ~200 batches of [(68)Ga]PSMA-11 for conducting PET-CT imaging in patients suspected/suffering from prostate cancer.
  
  
  
  The radiosynthesis of [(68)Ga]PSMA-11 was done in a hospital based nuclear medicine department using (68)Ge/(68)Ga generator and a manual synthesis module, both supplied by Isotope Technologies Garching (ITG), Germany. The production involved the reaction of 5μg (5.3nmol) of PSMA-11 ligand in 1 ml of 0.25M sodium acetate buffer with 4ml of (68)GaCl3 in 0.05M HCl for 5min at 105°C; followed by purification in a C18 cartridge and collection through a 0.22μm pore size filter.
  
  
  
  The radiochemical yields obtained were consistently high, 93.19%±3.76%, and there was hardly any batch failure. The radiochemical purity of the product was >99% and the product was stable for over 2h; however it was used in patients immediately after preparation. About 200 batches of [(68)Ga]PSMA-11 were prepared during the period and more than 300 patients received the tracer during the 14months of study. No adverse reaction was observed in any of the patients and the image qualities were consistent with literature reports.
  
  
  
  [(68)Ga]PSMA-11 with high radiochemical and radionuclidic purity is conveniently prepared by using a (68)Ge/(68)Ga generator and manual synthesis module. The radiochemical yields are very high; and activity sufficient for 3-4 patients can be prepared in a single batch; multiple batches can be done on the same day and when needed after a gap of 1.5-2h.
authors.affiliation: KIMS DDNMRC, Trivandrum, Kerala, India, 691601.
authors.forename: Raviteja
authors.initials: R
authors.lastname: Nanabala
authors.affiliation: KIMS DDNMRC, Trivandrum, Kerala, India, 691601.
authors.forename: Muhammed K
authors.initials: MK
authors.lastname: Anees
authors.affiliation: KIMS DDNMRC, Trivandrum, Kerala, India, 691601.
authors.forename: Arun
authors.initials: A
authors.lastname: Sasikumar
authors.affiliation: KIMS DDNMRC, Trivandrum, Kerala, India, 691601.
authors.forename: Ajith
authors.initials: A
authors.lastname: Joy
authors.affiliation: Molecular Group of Companies, Puthuvype, Ernakulam, Kerala, 682508. Electronic address: pillai.m.r.a@gmail.com.
authors.forename: M R A
authors.initials: MR
authors.lastname: Pillai
mesh_terms: D060326:Chemistry Techniques, Synthetic; D004355:Drug Stability; D004492:Edetic Acid / Q000031:analogs & derivatives; D005709:Gallium Isotopes; D005710:Gallium Radioisotopes / Q000737:chemistry*; D005857:Germanium / Q000737:chemistry*; D009842:Oligopeptides; D009942:Organometallic Compounds / Q000138:chemical synthesis* / Q000737:chemistry; D000072078:Positron Emission Tomography Computed Tomography; D011786:Quality Control; D011854:Radiochemistry / Q000379:methods*
chemical_list: D005709:Gallium Isotopes; D005710:Gallium Radioisotopes; D009842:Oligopeptides; D009942:Organometallic Compounds; C000718244:gallium 68 PSMA-11; D005857:Germanium; D004492:Edetic Acid
keywords: (68)Ga-PSMA-11; (68)Ge/(68)Ga generator; PET–CT imaging; PSMA inhibitor; Prostate cancer; Radiolabeling