title: Lutetium-177 DOTATATE Production with an Automated Radiopharmaceutical Synthesis System.
abstract: OBJECTIVE
  Peptide Receptor Radionuclide Therapy (PRRT) with yttrium-90 ((90)Y) and lutetium-177 ((177)Lu)-labelled SST analogues are now therapy option for patients who have failed to respond to conventional medical therapy. In-house production with automated PRRT synthesis systems have clear advantages over manual methods resulting in increasing use in hospital-based radiopharmacies. We report on our one year experience with an automated radiopharmaceutical synthesis system.
  
  
  METHODS
  All syntheses were carried out using the Eckert & Ziegler Eurotope's Modular-Lab Pharm Tracer® automated synthesis system. All materials and methods used were followed as instructed by the manufacturer of the system (Eckert & Ziegler Eurotope, Berlin, Germany). Sterile, GMP-certified, no-carrier added (NCA) (177)Lu was used with GMP-certified peptide. An audit trail was also produced and saved by the system. The quality of the final product was assessed after each synthesis by ITLC-SG and HPLC methods.
  
  
  RESULTS
  A total of 17 [(177)Lu]-DOTATATE syntheses were performed between August 2013 and December 2014. The amount of radioactive [(177)Lu]-DOTATATE produced by each synthesis varied between 10-40 GBq and was dependant on the number of patients being treated on a given day. Thirteen individuals received a total of 37 individual treatment administrations in this period. There were no issues and failures with the system or the synthesis cassettes. The average radiochemical purity as determined by ITLC was above 99% (99.8 ± 0.05%) and the average radiochemical purity as determined by HPLC technique was above 97% (97.3 ± 1.5%) for this period.
  
  
  CONCLUSIONS
  The automated synthesis of [(177)Lu]-DOTATATE using Eckert & Ziegler Eurotope's Modular-Lab Pharm Tracer® system is a robust, convenient and high yield approach to the radiolabelling of DOTATATE peptide benefiting from the use of NCA (177)Lu and almost negligible radiation exposure of the operators.
authors.affiliation: Department of Nuclear Medicine, Royal North Shore Hospital, Sydney, Australia; Sydney Medical School, University of Sydney, Sydney, Australia.
authors.forename: Alireza
authors.initials: A
authors.lastname: Aslani
authors.affiliation: Department of Nuclear Medicine, Royal North Shore Hospital, Sydney, Australia.
authors.forename: Graeme M
authors.initials: GM
authors.lastname: Snowdon
authors.affiliation: Department of Nuclear Medicine, Royal North Shore Hospital, Sydney, Australia; Faculty of Health Sciences, University of Sydney, Sydney, Australia.
authors.forename: Dale L
authors.initials: DL
authors.lastname: Bailey
authors.affiliation: Department of Nuclear Medicine, Royal North Shore Hospital, Sydney, Australia; Sydney Medical School, University of Sydney, Sydney, Australia.
authors.forename: Geoffrey P
authors.initials: GP
authors.lastname: Schembri
authors.affiliation: Department of Nuclear Medicine, Royal North Shore Hospital, Sydney, Australia.
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Bailey
authors.affiliation: Sydney Medical School, University of Sydney, Sydney, Australia; Department of Medical Oncology, Royal North Shore Hospital, Sydney, Australia.
authors.forename: Nick
authors.initials: N
authors.lastname: Pavlakis
authors.affiliation: Department of Nuclear Medicine, Royal North Shore Hospital, Sydney, Australia; Sydney Medical School, University of Sydney, Sydney, Australia.
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Roach
keywords: Automated synthesis; Lutetium-DOTATATE; Neuroendocrine tumours; Peptide Receptor Radionuclide Therapy