SBIR Phase I: PET Radiotracer Synthesis

This Small Business Innovation Research Phase I project will support a new synthetic chemical approach for the creation of positron emission tomography (PET) imaging products to manage neurodegenerative disorders, cancer, and cardiovascular disease. Creating these imaging products relies on the rapid and efficient labeling of tracer molecules with a radioisotope ([18F]fluoride). The difficulties inherent in radiofluorination chemistry have severely limited the scope of radiotracers available for clinical use. This NSF SBIR Phase 1 project addresses this critical problem using the company?s proprietary single-step fluorination technology. This technology advances the current state-of-the-art with simple, fast, and highly efficient radiofluorination, permitting an entire new class of drugs to be labeled with no-carrier-added [18F]fluoride for the first time. The project will focus on the synthesis of clinically relevant radiotracers for pediatric cancer and Parkinson?s disease. Technical studies to be performed using this support include optimization of this new radiofluorination manufacturing methodology across multiple radiosynthesis platforms. The broader impact/commercial potential of this project is to provide technology to expand the scope of PET as a platform for determining the identification and staging of diseases, and assessing the efficacy of treatment regimens. PET is an underutilized diagnostic imaging technique that is stymied by the lack of highly efficient, broadly applicable radiofluorination methods. The radiotracer manufacturing technology developed here is extremely general and applicable to the preparation of new imaging agents for PET. The availability of this general labeling technique can also speed development of new drugs by providing in vivo biomarkers of new therapeutic agents which can be used to determine optimal dosing of new drugs and variability of biodistribution in target populations. The commercial potential of PET imaging is significant; the worldwide market for PET is expected to grow to $15 billion by 2015. There is also room for significant expansion of this market as new imaging agents become available.