CHICAGO - Access to 18F-FDG need not be a problem to the enterprising imaging facility that makes its own, according to Italian physicians who presented here at the 2003 RSNA meeting.
“We decided to synthesize our own 18F-FDG because no one in our region had a license to sell it,” said principal investigator Dr. Arturo Chiti. “In May of 2002 we obtained permission to synthesize our own radiopharmaceutical without a license, and in June, 2003, our cyclotron was licensed.”
Chiti, the medical director of the nuclear medicine
department of Istituto Clinico Humanitas in
Initially they used an off-site supply of 18F. Key to safe preparation of the material was an automatic dose dispenser, which allowed for quality control with minimal operator exposure to radiopharmaceuticals.
The material had an average activity of 37 GBq of 18F-fluoride and was produced by 18O (n,p)18F nuclear reaction using an 18 MeV cyclotron. The radiopharmaceutical was transported daily by car in a lead-shielded vial. Once the 18F had arrived in their laboratory, the radiochemists waited approximately one hour after production to insert the radionuclide into the hot-cell and transfer it to the synthesis module through a vacuum and argon pressurizing system. The system also had Teflon tubing 1/16” in diameter.
The involved staff at Chiti’s facility found that they needed 25 minutes to synthesize 18F-FDG with 50 ± 3% EOS radiochemical yield. The purified final product was then directly released and collected into a dose dispenser unit that operated with a process control box connected to a personal computer. This system allowed the staff to prepare a calibrated dose of 18F-FDG in sterile syringes.
The quality control protocols that the facility has in place follow the quality assurance procedures required for 18F-FDG injection. When the quality control protocols are considered, the total preparation time is 40 minutes.
Although the facility now has its own cyclotron, Chiti stressed that a system like this offers a useful and affordable way to obtain 18F-FDG without an on-site cyclotron and allows an imaging center to offer clinical PET. He noted the value of having an automatic transport system and dose dispenser, both of which significantly reduce the operators' radiation exposure and optimize the accuracy of dose preparation. “We were one of the first centers to use an automatic dispenser,” he said.
By Paula Moyer
AuntMinnie.com contributing writer
December 3, 2003
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