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. 2015 Summer;3(2):107-15.

Lutetium-177 DOTATATE Production with an Automated Radiopharmaceutical Synthesis System

Alireza Aslani  1 , Graeme M Snowdon  2 , Dale L Bailey  3 , Geoffrey P Schembri  1 , Elizabeth A Bailey  2 , Nick Pavlakis  4 , Paul J Roach  1
Affiliations

Lutetium-177 DOTATATE Production with an Automated Radiopharmaceutical Synthesis System

Alireza Aslani et al. Asia Ocean J Nucl Med Biol. 2015 Summer.

Abstract

Objectives: 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.

Keywords: Automated synthesis; Lutetium-DOTATATE; Neuroendocrine tumours; Peptide Receptor Radionuclide Therapy.

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Figures

Figure 1
Figure 1
Pressure test trace indicating a pressure test Pass (top) and a Fail (bottom)
Figure 2
Figure 2
Example of representative images from a single individual showing [68Ga]-DOTATATE PET scan (MIP image) (left) and after infusion of ~6.4 GBq of [177Lu]-DOTATATE at four time points. The gamma camera images are geometric mean (GM) images that have been corrected for attenuation using a pre-acquired transmission scan and converted to units of radioactivity (kBq) The distribution of disease on [177Lu]-DOTATATE images is identical to that seen on the preceding diagnostic [68Ga]-DOTATATE scan
Figure 3
Figure 3
Average [177Lu]-DOTATATE yields and radiochemical (RC) purity by ITLC and HPLC
Figure 4
Figure 4
A typical chromatogram report for radiolabelled [177Lu]-DOTATATE product
See this image and copyright information in PMC

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