I am the director of the Cyclotron facility at Parker Hall.
Abbreviated new drug applications (ANDA) are submitted to the Food and Drug Administration for 18F-Fluorodeoxyglucose (FDG) and 13N-Ammonia. Future centers producing PET radiopharmaceuticals must have ANDA for clinical use drugs or Investigational new drug application (IND) approved by FDA for research use Radiopharmaceuticals. Our facility was audited and I am working with FDA on their concerns.
18F-Fluorodeoxyglucose (FDG) and 13N-Ammonia are produced for clinical use in our department and the community at large. These labeled drugs are used by different hospital in this area for clinical imaging. We also produce the following radiopharmaceuticals for human use. 11C-meta-hydroxyephedrine is produced to study for the non-invasive delineation of functional sympathetic nerves. 11C-Raclopride is for brain imaging for D2 receptor, 11C-PIB for amyloid imaging and 11C-Choline for prostate cancer. These radiopharmaceuticals are used for research studies. We have an Investigational New drug (IND) approval for 11C-meta-hydroxyephedrine, 11C-PIB and 11C-Raclopride from the Food and Drug administration.
Iodine-124 is produced in our facility. We have developed the targetry system to produce this positron emitter of Iodine. It is used to label drugs with longer biological half-life. Photodynamic Therapy (PDT) compounds, antibodies and Paclitaxel were all labeled with Iodine-124. I also perform mice studies i.e. biodistribution and microPET studies. We have Focus120 microPET. The research on PDT compounds is moving forward with collaboration with the PDT group of Roswell Park Cancer Institute. A number of 124I -labeled PDT compounds are tested in different
Animal models. The goal is to develop one compound for imaging (Fluorescence and nuclear
imaging) and for PDT therapy. As of the same molecule represents the contrast medium and the therapeutic medium , the lesion(s) can be continuously imaged during needle/fiber placement for PDT therapy, without any ambiguity in terms of localization or “misregistration” of separate diagnostic/therapeutic images.