Synthesis and quality control of 68Ga citrate for routine clinical PET.
OBJECTIVE
Scintigraphic imaging of infection and inflammation with 67Ga-citrate is an established and powerful diagnostic tool in the management of patients with infectious or inflammatory diseases. 68Ga is a short-lived positron-emitting radionuclide (half-life 67.6 min, positron energy 2.92 MeV), which allows better imaging qualities than 67Ga using the high spatial resolution and the quantitative features of PET. The aim of this study was to develop a method of synthesis for 68Ga citrate with high and reproducible radiochemical yield using a commercial 68Ga-labelling module. The resultant 68Ga citrate would be suitable for use in the detection of infectious or inflammatory diseases in routine clinical practice.


METHODS
A simplified method of producing 68Ga citrate is described. Radiochemical purity, pyrogen testing were performed as per the standard protocols.


RESULTS
After performing 10 syntheses of 68Ga citrate, the radiochemical yield was 64.1+/-6.0% (mean+/-standard deviation) with an average activity of 971.2+/-103.4 MBq available for labelling. Radiochemical purity determined by instant thin-layer chromatography-silica gel was higher than 98%. All the synthesized products were found to be sterile and pyrogen-free. In this study, the quality control step provided good and reproducible results. This is worth noting, especially in view of the stringent new rules adopted in most European countries for the in-house good manufacturing practice (GMP) synthesis of radiopharmaceuticals.


CONCLUSIONS
The high radiochemical yield and purity showed that this method is a reliable tool for the production of 68Ga citrate to be used in the detection of inflammatory and infectious diseases using high resolution and qualitative PET.
Rizzello
Anna
A
Department of Nuclear Medicine, PET Radiopharmacy, Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.
Di Pierro
Donato
D
Lodi
Filippo
F
Trespidi
Silvia
S
Cicoria
Gianfranco
G
Pancaldi
Davide
D
Nanni
Cristina
C
Marengo
Mario
M
Marzola
Maria Cristina
MC
Al-Nahhas
Adil
A
Rubello
Domenico
D
Boschi
Stefano
S
D002951:Citrates / Q000138:chemical synthesis* / Q000737:chemistry / Q000592:standards; D003141:Communicable Diseases / Q000000981:diagnostic imaging; D005708:Gallium / Q000737:chemistry / Q000592:standards; D005710:Gallium Radioisotopes / Q000737:chemistry; D006801:Humans; D006863:Hydrogen-Ion Concentration; D007249:Inflammation / Q000000981:diagnostic imaging; D015282:Octreotide / Q000031:analogs & derivatives / Q000737:chemistry; D049268:Positron-Emission Tomography; D011786:Quality Control; D015203:Reproducibility of Results; D013194:Staining and Labeling
D002951:Citrates; D005710:Gallium Radioisotopes; D005708:Gallium; C103850:gallium citrate; D015282:Octreotide; C106246:Edotreotide