Examples of Collaborative Clinical Studies with
ORNL Developed Technologies
Although ORNL is not licensed to distribute radioisotopes and radiopharmaceuticals approved for human use, a number of agents, techologies and radionuclide generators systems developed in the ORNL Nuclear Medicine Program are distributed through the ORNL Isotopes Business Office as radiochemicals for research and clinical studies being conducted at institutions throughout the world. Clinical studies are conducted under physician- sponsored protocols. The Nuclear Medicine Program offers technical expertise and guidance on the use of medical radioisotopes to the there collaboration. Key examples of ORNL products being used in clinical research include the tungsten-188/rhenium-188 generator system developed at ORNL, where rhenium-188 is being used for a variety of therapeutic applications in over multiple clinical projects throughout the world in the areas of nuclear medicine, oncology and interventional cardiology. In addition, bismuth-213 is being used for cancer therapy at a variety of centers and is available from the actinium-225/bismuth-213 generator system, using actinium-225 provided from ORNL.
Rhenium-188 from the ORNL generator is widely used for therapeutic applications in nuclear medicine, oncology and interventional cardiology/radiology, including the palliative treatment of unresectable liver cancer and palliative therapy of metastatic bone pain, and for inhibition of arterial restenosis after PCA. Bismuth-213 and actinium-225 are being evaluated for various therapeutic applications, and the major current use is for the treatment of acute myeloid leukemia. Other examples of the clinical introduction of ORNL-developed radiopharmaceutical technologies include use of the iodine-123-BMIPP cardiac imaging, which provides unique metabolic information of the left ventricular myocardium. This agent has been used in > 1 million clinical studies in Japan, and is currently in Phase III clinical studies in the U. S. The osmium-191/iridium-191m generator had provided ultra short-live iridium-191m (4.96 sec) for first pass ventriculography for evaluation of left ventricular ejection fraction and wall motion assessment.
 |
 |
| Use of rhenium-188 from the ORNL tungsten-188/rhenium-188 generator for radioembolytic therapy of liver cancer (courtesy of H. Turner, M.D., Fremantle, Australia) | |
 |
|
| Treatment of liver cancer by Radioembolization with Rhenium-188-N2S2-Lipiodol at Choroy Hospital in Ho Chi Minh City, Vietnam (courtesy, Drs. Chau and Sundram) | |
|
 |
| Administration of the rhenium-188 solution for radiation treatment of arterial site Rhenium-188 from the ORNL tungsten-188/rhenium-188 generator is used to prevent restenosis in post-angiographic treatment of coronary arteries, using the liquid-filled balloon approach developed in the ORNL Nuclear Medicine Program (courtesy of J. Kropp, M.D., University Hospital, Dresden, Germany) | |
|
 |
|
Inflation of angioplasty
balloon with radioactive rhenium-188 solution |
|
|
|
| Example of use of the ORNL-developed BMIPP cardiac imaging study in a patient at the Clinic for Nuclear Medicine in Bonn, Germany (courtesy of J. Kropp, M.D., University Hospital, Dresden, Germany) | |
 |
|
First-pass cardiac studies with short-lived iridium-191m at the Clinic for Nuclear Medicine, University of Bonn, Germany, using the ORNL-developed osmium-191/iridium-191m generator (courtesy of H.-J. Biersack, M.D.)
|
|
