There is a pressing need for designing new devices facilitating the development of paradigm changing, minimally invasive, approaches to treat diseased tissues in situ. Additionally, there is a growing number of studies showing that combinatorial approaches are providing a path for personalization of strategies to treat a wide array of disease states. While providing a promising path to revolutionize medicine, the evolution of personalized, minimally invasive, combinatorial therapies has been slowed as a result of technological limitations. As such, there is a pressing need for new medical devices to enable the development of trans-disciplinary strategies to combat disease. This Phase 1 project is designed to address this need through the development of a new flexible endoscopic compatible catheter designed for the treatment of various gastrointestinal related tissue diseases enabling the application of multiple therapeutic and diagnostic approaches (pharmaceutical, dual-ablation, cell and gene therapy, among others) in a single device format (FrostBite). The ability to deliver multi- parametric treatment regimes of the FrostBite catheter is enhanced by its compatibility with advanced imaging approaches including endoscopic ultrasound, MRI, and CT. Initial R&D activities have resulted in a prototype 1.5mm needle tip catheter capable of delivering dual thermal insults to a target within 10 seconds creating a zone of destruction of ~2.5cm in less than 2 mins. Preliminary studies into combinatorial drug/thermal insults have shown improved outcomes in tissue models as well. Under this proposal we intend to develop and test this next generation endoscopic compatible catheter as well as evaluate a series of combinatorial strategies. Successful completion of this project will provide for a novel medical device enabling the development and application of advanced personalized treatment regimes for 100's of thousands of patients who suffer from numerous gastrointestinal tissue disease states which are untreatable or inadequately treated with today's state of the art devices.

Public Health Relevance

The intent of this project is to develop a novel catheter for the treatment of gastrointestinal cancers that include pancreatic cancer. CPSI Biotech has already developed the engine behind this system that relies on the use of super critical nitrogen. This system will be commercially introduced in late 2013 for treating prostate cancer. Now the company plans to develop a unique set of endoscopic probes that can be used with this engine to more effectively eradicate diseased tissues.

National Institute of Health (NIH)
National Cancer Institute (NCI)
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
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Special Emphasis Panel (ZRG1-SBIB-Y (12))
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Zhao, Ming
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Cell Preservation Services, Inc.
United States
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Baumann, Kenneth W; Baust, John M; Snyder, Kristi K et al. (2017) Characterization of Pancreatic Cancer Cell Thermal Response to Heat Ablation or Cryoablation. Technol Cancer Res Treat 16:393-405
Santucci, Kimberly L; Baust, John M; Snyder, Kristi K et al. (2016) Investigation of the Impact of Cell Cycle Stage on Freeze Response Sensitivity of Androgen-Insensitive Prostate Cancer. Technol Cancer Res Treat 15:609-17