In the future we will need to develop new precision tools for early detection and precision treatment of cancer, neurological disorders, cardiovascular diseases, inflammatory conditions, infection, and chronic pain syndromes. Imaging using radiopharmaceuticals that can target and track changes at a molecular level, combined with the ability to turn these diagnostic tools into treatments called theragnostics (diagnostics + therapy), are the most advanced tools to get us there. For the past 15 years the Department of Radiology has invested in and built a world-class molecular imaging program that includes a Cyclotron and Radiochemistry Facility (CRF) for the development of such diagnostic radiopharmaceuticals. In order to stay in front of the field, and advance our clinical care, additional infrastructure is needed for the development of new radioisotopes and theragnostic probes.

The production of radioactive isotopes requires a cyclotron; a compact particle accelerator that produces radioactive isotopes that can be used for diagnostic imaging and/or therapeutic purposes. A cyclotron is required for positron emission tomography and theragnostics because the isotopes that are used for imaging and therapy decay over periods of minutes to hours. The addition of a second, more advanced, cyclotron and radiochemistry facility will form a new Stanford Molecular and Radionuclide Theragnostics Center. The Center will include (1) the new capability of solid targets, which allows for production of new isotopes not yet available at Stanford as well as in house production of long-lived isotopes that today are ordered from outside vendors and we therefore have limited and unreliable access to, (2) space and equipment for theragnostic radiolabeling and dispensing for human translation, and (3) additional space (3,500 sq ft) to grow our current radiochemistry program that has outgrown the space in the current CRF at Lucas (2,500 sq ft.)

Solid targets, automated dispensing and space and equipment for theragnostic radiolabeling cannot be added in our current CRF facility. The addition of a second cyclotron and space would more than double our capacity; preclinical research could be moved there from our Lucas facility and provide the Lucas facility with the ability to expand the clinical production by up to 40%. This will provide added support for the clinical requests, the PET/MR program, and the new biology guided radiotherapy (RefleXion X1) program in Radiation Oncology.

Personalized and non-invasive treatment for cancer is projected to drive the growth in the nuclear medicine market (from ~$6B currently to ~$14B in a pessimistic estimate or ~$30B in an optimistic estimate by 2027). In addition, research in molecular imaging provides a view of protein and gene expression over time and space within patients and living animals and is therefore essential for competitive research funding across multiple disciplines at Stanford. For example, NIH brain initiatives are fueling research in PET imaging. Researchers spanning Cardiology, Medical Oncology, Neurology, Pathology, Psychiatry, Radiation Oncology, Radiology and Surgery collaborate by applying imaging to projects spanning basic research to clinical translation. Additionally, this center will provide the infrastructure and cutting-edge technologies to train and educate future leaders in basic and clinical science. This is a vision that closely aligns with Stanford University School of Medicine stated goals.

The new Center will allow Stanford to significantly expand research capabilities for both preclinical and clinical research radiotracer development, expanding the access to users across campus. We organize this report by describing the growth in activity over time, areas projected for additional growth, the proposed Center, a SWOT analysis and finally lists of radiopharmaceuticals and participating faculty are included in the appendices.

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