Modernization of the Yale PET Core - Positron Emission Tomography (PET) is a powerful imaging modality that enables visualization and quantification of biological functions using radiopharmaceuticals. However, due to the short half-lives of PET isotopes (e.g., 20 minutes for C-11, 2 hours for F-18), the entire process from cyclotron to radiopharmaceutical synthesis to quality control to injection, and imaging must be streamlined to ensure efficiency and radiochemical yield. The radiopharmacy facilities at the Yale School of Medicine (YSM) are housed within the Yale PET Core which operates as a revenue-neutral inter-service provider offering full PET study services exclusively for research. The PET Core serves investigators in psychiatry, neurology, cardiology, endocrinology, and basic neuroscience. Investigators are part of a large NIH-funded community at Yale and throughout New England, as well as several institutions nationally through clinical trials recruiting subjects in the Yale PET Core. Since its inception in 2006, the PET Core has grown rapidly, performing PET imaging research studies in humans and a variety of animal species. Over 1,100 scans are projected for 2025. Despite a significant increase in the number of scanners and efficiency in the PET Core, radiochemistry production capabilities have not grown accordingly. Currently, there are 7 PET scanners available for routine use, with more expected to be installed shortly, while the radiopharmacy facilities were originally designed to support radiotracer production for 3 PET scanners. To operate available PET scanners at full capacity, the PET core will require a substantial increase to the existing radiochemistry infrastructure. This would significantly reduce the waiting time (4-6 weeks) to perform a PET scan. Furthermore, a unique opportunity exists to expand and update the PET Core facilities to bring the radiopharmacy manufacturing to 21 CFR Part 212 current Good Manufacturing Practice (cGMP) for PET drug production. Since the radiochemistry and radiopharmacy facilities have not undergone a major redesign since 2006, a significant upgrade is necessary. This will enable the production of approved compounds in the areas of oncology, neurodegeneration and cardiac imaging, while enabling shipping radiopharmaceuticals for human use outside the Yale campus. Most importantly, the expansion and upgrades to the radiochemistry facilities will enhance the investigators’ ability to efficiently work on the discovery and development of novel radiochemistry compounds focused on the detection, understanding, and treatment of disease and streamline translation to radiopharmaceutical production. The PET Core multi-phase renovation and expansion project will occur within the Magnetic Resonance Research Center building (MRC). The requested C06 funds will be used in three phases to: i) build a new radiochemistry/radiopharmacy/QC Lab cGMP suite, ii) upgrade the existing radiochemistry lab to cGMP, and iii) convert the QC lab to a research hot chemistry lab. This scope will accelerate discovery and development of novel radiochemistry compounds, enable shipping of PET radiotracers to outside entities, reduce waiting time for PET imaging and maximize Yale’s unique PET resources’ reach and accessibility.
