Nuclear Medicine, Inc. has developed the first filter device to generate a deeply-penetrating, high flux epithermal neutron beam free of significant fast neutron contamination. The device is a prototype of a therapeutic version intended for use in an alternative form of radiation therapy known as Boron Neutron Capture Therapy. The epithermal neutron beam will ultimately be coupled with NMI's Orphan Drug, Na210B12H11SH, for the treatment of an extremely malignant brain tumor known as glioblastoma multiforme. Upon FDA approval of both the drug and device, radiation services will be offered, much like those in radiation therapy and oncology departments in major hospitals. Phase I consists of rebuilding and optimizing the prototype device for therapeutic purposes. Phase II involves extensive characterization of the resultant epithermal neutron beam, fulfilling FDA requirements for an investigational Device Exemption application. Phase II then continues with two animal studies to assess the safety of the glioblastoma treatment. The results of these studies will finalize protocols for clinical trials of epithermal neutron - BNCT.
