BRF: National Translational Research Facility for Neutron Capture Therapy (NCT) - Project Summary Neutron capture therapy (NCT) is a highly promising molecularly targeted radiation modality that enables selective, high-LET energy deposition within tumor cells through neutron-activated capture agents, offering the potential to overcome resistance to conventional radiation therapies while minimizing normal tissue toxicity. Although NCT has demonstrated promising clinical outcomes internationally and is experiencing a rapid resurgence driven by advances in accelerator-based neutron sources and targeted therapeutic platforms, the United States lacks an accelerator-based clinical neutron-beam research facility capable of supporting modern preclinical, translational, and early-phase clinical investigation. This absence represents a critical gap in national biomedical research infrastructure that limits U.S. competitiveness in drug development, translational validation, and regulatory advancement of next-generation neutron-capture agents. This project proposes establishment of the first accelerator-based NCT translational research facility in the United States at the University of Wisconsin– Madison, within the Wisconsin Institutes for Medical Research (WIMR). The facility will house an integrated Neutron Capture Therapy Translation Research Laboratory unifying radiochemistry, biological validation, advanced imaging, and neutron irradiation within a single, purpose-built, coordinated research environment. Facility organization aligns spatial layout with the temporal sequence of NCT research workflows, preserving experimental timing, reducing variability, and enabling controlled, reproducible translational studies not achievable within existing domestic infrastructure. The project encompasses approximately 30,000 gross square feet across two levels, including a shielded accelerator room and irradiation suite, experimental support laboratories, controlled circulation and safety systems, translational research laboratories, and contiguous shell space to accommodate future cGMP and translational expansion as NCT technologies evolve. The design is informed by advanced coordination with neutron system vendors, medical physicists, and radiation safety experts, incorporating validated shielding strategies and equipment-driven engineering compliant with NIH Design Requirements Manual criteria. UW–Madison provides a uniquely qualified institutional environment, with an NCI-designated comprehensive cancer center, internationally recognized expertise in medical physics, radiation oncology, imaging sciences, radiochemistry, and translational oncology, and one of the few academic cyclotrons capable of producing novel isotopes relevant to NCT. Strong industry partnerships and committed institutional support for operations, staffing, and sustainability ensure long-term viability. Establishment of this facility will address a critical national infrastructure deficiency, catalyze pharmaceutical innovation, enable domestic regulatory pathways for NCT agents, and position the United States to lead the next phase of innovation, validation, translation, and clinical advancement in neutron capture therapy.
