Rhenium-188 is a high energy beta-emitting radioisotope obtained from the tungsten-188/rhenium-188 generator, which has shown utility for a variety of therapeutic applications in nuclear medicine, oncology and interventional radiology/cardiology.
The Drug Master File (DMF) for ORNL manufacturing of tungsten-188/rhenium-188 generators has been registered with the Food and Drug Administration (FDA). The DMF coupled with the imminent implementation of current Good Manufacturing Practices (cGMP) will facilitate broader use of this generator system in nuclear medicine clinical trials for cancer treatment internationally. The tungsten-188 is produced by the irradiation of calutron-enriched tungsten-186 in the HFIR followed by recovery, processing and fabrication of the tungsten-188/rhenium-188 generators.
Tungsten-88/rhenium-188 generators are distributed from ORNL internationally. The generators are fabricated in dedicated hot cell facilities located in the ORNL Nuclear Science and Analytical Chemistry Building 4501.
The rhenium-188 is in demand for a variety of research and clinical applications, including for treatment of metastatic bone cancer, non-resectable liver cancer, non-melanoma skin cancer, treatment of arthritis and for inhibition of arterial restenosis following balloon angioplasty. Many of these applications are using ORNL-developed technologies. A Phase 2 clinical study using technology developed at Yeshiva is in progress following the Phase I study at Hadassah Hospital in Israel, which began recruiting patients in January 2009, where the ORNL generators are used for preparation of a new antibody for therapy of metastatic melanoma.