North Shore-LIJ receives FDA approval for new drug application to manufacture PET scan drug

ures used in the manufacture of the drug.

Fludeoxyglucose F 18 is the most widely used radiopharmaceutical in PET scanning. A radiopharmaceutical is a specially designed drug that consists of a molecular compound that is similar to one normally used by cells -- in this case, glucose -- but which is tagged with radioactive atoms. When the cell absorbs the radiopharmaceutical, gamma rays are released as the unstable radioactive atoms rearrange themselves into a stable configuration. Traveling at the speed of light, the gamma rays allow the PET camera to generate a picture of those cells and organs at work. The amount of radiation to which a person is exposed is minimal and compares to that of a basic X-ray or CT scan.

Radioactive fluorine atoms are produced by a cyclotron, like the state-of-the-art GE PETrace Cyclotron purchased by North Shore-LIJ last year and installed at its research institute at a total cost of $2.6 million. It is the only cyclotron on Long Island used to produce radiopharmaceuticals for both research and clinical PET scanning. Once the radioactive atoms are produced, a sophisticated radiochemistry instrument such as a Fludeoxyglucose synthesizer incorporates the radioactive atoms into a chemical compound such as deoxyglucose and produces the drug. Fludeoxyglucose F 18 is manufactured in a saline solution, stored in glass vials and injected intravenously just prior to the actual PET scanning procedure.

The speed of radioactive decay of Fludeoxyglucose F 18, or its half-life, is just under two hours. This means that every two hours, half of its radiation-emitting ability is lost. Therefore, the drug must be used the same day it is manufactured, often within just hours of production -- creating a challenge for transporting the drug over any distance. The drug strength produced depends on the capacity of the cyclotron. The greater the strength that can be made, the more drug is available for PET imaging studies and the farthe

Contact: Christina Verni
North Shore-Long Island Jewish (LIJ) Health System

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