Regional distribution of 2-deoxy-2[18F]-fluoro-D-glucose for metabolic imaging using positron emission tomography

Radiopharmaceutical availability is one of the reasons dissemination and growth of clinical PET imaging remains problematic. A 'regional' cyclotron-radiopharmacy facility for the production of the positron emitting radionuclide 2-deoxy-2[18F]-fluoro-D-glucose (FDG), has been operational for over 2 years and supplies this radiopharmaceutical to five camera facilities, four distant and one on-site. The RDS 11 MeV cyclotron is capable of dual bombardment of targets yielding 60 GBq (1600 mCi) of F-18 in a 90 minute period. F-18 labelled FDG is produced by an automated synthesis module yielding 22.2 GBq (600 mCi) FDG. The PET radiopharmacy is required to perform extensive quality assurance activities including a number of tests to insure final product and safety. [18F]FDG is shipped in unit dose vials, 6 ml, two per shielded container, meeting Department of Transportation (DOT) specifications (43 x 43 cm cubes, styrofoam packing, 22 lb. lead shield). This adheres to regulations requiring no more than 200 millirem per hour (mR/Hr) exposure at the container surface, and 10 mR/hr at a distance of 1 meter. Total transport time, utilizing private air and ground couriers, to distant facilities is approximately 100-120 minutes. Based on patient scheduling and protocol used, allowing 45-60 minutes between dose administrations, and availability of 22.2 GBq (600 mCi), 20-22 unit doses can be supplied, divided and shipped in a number of ways. The regional-commercial distribution of PET radiopharmaceuticals, specifically [18F]FDG, is feasible. This provides availability of metabolic imaging at sites distant to radiopharmaceutical production.