Cyclotron-based production of 68Ga, [68Ga]GaCl3, and [68Ga]Ga-PSMA-11 from a liquid target

EJNMMI Radiopharmacy and Chemistry

Stefan Eberl¹  Michael J. Fulham²  Andrew Katsifis³  Daniela Stark³  Melissa E. Rodnick⁴  Peter J. H. Scott⁴  Mara Clark⁴  Monica Abghari-Gerst⁴  Brian G. Hockley⁴  Bradford D. Henderson⁴  Morand R. Piert⁴  Jens Frigell⁵  D. Christian Parr⁵  Katherine Gagnon⁵  Carina Sollert⁵ 

[1] Department of Molecular Imaging, Royal Prince Alfred Hospital and School of Computer Science, The University of Sydney, Sydney, Australia;Department of Molecular Imaging, Royal Prince Alfred Hospital and Sydney Medical School, University of Sydney, Sydney, Australia;Department of Molecular Imaging, Royal Prince Alfred Hospital, Sydney, Australia;Division of Nuclear Medicine, Department of Radiology, University of Michigan, Ann Arbor, MI, USA;GE Healthcare, GEMS PET Systems, Uppsala, Sweden;

关键词: Gallium-68;    Cyclotron targetry;    Positron emission tomography;    PSMA;   

DOI  :  10.1186/s41181-020-00106-9

来源: Springer

【 摘 要 】

PurposeTo optimize the direct production of 68Ga on a cyclotron, via the 68Zn(p,n)68Ga reaction using a liquid cyclotron target. We Investigated the yield of cyclotron-produced 68Ga, extraction of [68Ga]GaCl3 and subsequent [68Ga]Ga-PSMA-11 labeling using an automated synthesis module.MethodsIrradiations of a 1.0 M solution of [68Zn]Zn(NO3)2 in dilute (0.2–0.3 M) HNO3 were conducted using GE PETtrace cyclotrons and GE 68Ga liquid targets. The proton beam energy was degraded to a nominal 14.3 MeV to minimize the co-production of 67Ga through the 68Zn(p,2n)67Ga reaction without unduly compromising 68Ga yields. We also evaluated the effects of varying beam times (50–75 min) and beam currents (27–40 μA). Crude 68Ga production was measured. The extraction of [68Ga]GaCl3 was performed using a 2 column solid phase method on the GE FASTlab Developer platform. Extracted [68Ga]GaCl3 was used to label [68Ga]Ga-PSMA-11 that was intended for clinical use.ResultsThe decay corrected yield of 68Ga at EOB was typically > 3.7 GBq (100 mCi) for a 60 min beam, with irradiations of [68Zn]Zn(NO3)2 at 0.3 M HNO3. Target/chemistry performance was more consistent when compared with 0.2 M HNO3. Radionuclidic purity of 68Ga was typically > 99.8% at EOB and met the requirements specified in the European Pharmacopoeia (< 2% combined 66/67Ga) for a practical clinical product shelf-life. The activity yield of [68Ga]GaCl3 was typically > 50% (~ 1.85 GBq, 50 mCi); yields improved as processes were optimized. Labeling yields for [68Ga]Ga-PSMA-11 were near quantitative (~ 1.67 GBq, 45 mCi) at EOS. Cyclotron produced [68Ga]Ga-PSMA-11 underwent full quality control, stability and sterility testing, and was implemented for human use at the University of Michigan as an Investigational New Drug through the US FDA and also at the Royal Prince Alfred Hospital (RPA).ConclusionDirect cyclotron irradiation of a liquid target provides clinically relevant quantities of [68Ga]Ga-PSMA-11 and is a viable alternative to traditional 68Ge/68Ga generators.

【 授权许可】

CC BY