The Medical Isotope Program is focused on the development of: improved reactor production and processing methods to provide medical radioisotopes; new radionuclide generator systems; design and evaluation of new radiopharmaceuticals for applications in nuclear medicine and oncology; and association with Medical Cooperative Programs throughout the world for the further pre-clinical testing and clinical evaluation of agents developed at ORNL. In the United States, only ORNL has the combined resources of a stable isotope inventory, the High Flux Isotope Reactor (HFIR), hot cell processing capabilities, and a wide range of support functions required for such research. These collective resources provide unique capabilities for nuclear medicine research and radioisotope production.
Our current research program primarily focuses on production and processing of therapeutic beta- and alpha-emitting radioisotopes and development and use of radionuclide generator systems. Many radioisotopes of current interest are produced in high specific activity using the ORNL High Flux Isotope Reactor (HFIR), which include high specific activity lutetium-177 and other lanthanides for targeted therapy, and tungsten-188 for the tungsten-188/rhenium-188 generator system. Rhenium-188 technologies developed at ORNL are currently used in a number of clinical protocols for treatment of nonresectable liver cancer, palliative treatment of metastatic bone pain, inhibition of arterial restenosis following angioplasty, and radiosynovectomy therapy of arthritis. The Drug Master File (DMF) for the generator is filed with the FDA, and manufacture under cGMP is being implemented. Another major ORNL area of therapeutic radioisotope research includes production of alpha-emitting radioisotope actinium-225, which is used in radiotherapy of cancer. Actinium-225 is routinely extracted from thorium-229 stock, and ORNL is currently the largest supplier of this medical radioisotope.
The ORNL Nuclear Medicine Research Program follows a long tradition of developing useful diagnostic and therapeutic applications of radioisotopes. Our research focuses on the development of: medical radioisotope processing techniques; radionuclide generator research; and new tissue-specific radiopharmaceuticals for diagnostic and therapeutic applications in nuclear medicine, oncology and interventional cardiology. Key strengths are radiopharmaceutical chemistry, radiochemistry, radioisotope process research, and biomedical applications. The ORNL High Flux Isotope Reactor (HFIR) represents an important resource that provides primarily neutron-rich radioisotopes. We are developing new processing procedures and making important contributions in developing new radionuclide generator systems, which provide radioisotopes for various therapeutic applications in tumor therapy and diagnosis. We collaborate with a variety of programs within ORNL and at universities, medical schools and other research institutions throughout the world. These Medical Cooperative Programs provide important opportunities for further pre-clinical research and clinical evaluation of new agents developed in our ORNL program. The clinical evaluation and commercialization of new agents developed at ORNL illustrate the important transition of our new technologies from the laboratory to routine clinical use.