Image-Guided System for Cancer Intervention

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Department of Health and Human Services
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Phase II
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DESCRIPTION (provided by applicant): This program will demonstrate the potential for commercial success of a novel approach for tracking and displaying the position and orientation of instruments in image-guided cancer interventions. Prototype systems will be demonstrated in selected pancreatic procedures in human subjects. New clinical applications will be examined and commercialization will begin for an accurate and cost-effective system to be used by physicians who intervene to cure cancer. An instru ment tracking system with a novel flat-plate transmitter suitable for human test and evaluation will be implemented and demonstrated. The real time position of surgical instruments and supporting devices will be displayed in the context of volumetric image s of the individual patient. This system will be evaluated for its potential to improve the surgical resection of pancreatic tumors in human patients. The tracking system will be used to display real time information in open and laparoscopic procedures, an d its potential benefits gauged by the surgeon and trained observers through analysis after the completion of each case. Iterative improvements will be made to the system as experience is gained in human subject procedures. The system will also be evaluate d for its potential to improve the guidance and ease of use of gastroscopic ultrasound- guided biopsies of the pancreas including tests in human subjects. Techniques for guiding access to the abdomen through the stomach wall will be developed and other nov el approaches with great potential in image-guided interventions to remove cancer tumors will be explored. The tracking device will be integrated into the instruments used in trans-anal and possibly trans-vaginal procedures. The utility tracking platform t o guide regional and local cancer treatment, local drug delivery, and the placement of markers to guide subsequent radiation therapy will also be investigated. A product and commercialization plan will be developed. This plan will be based on an extension and expansion of the current product and business strategy of Ascension Technology Corporation in conjunction with laparoscopic ultrasound manufacturer, B-K Medical. Among other elements, it will include production engineering, market and competitive analy sis, the protection of intellectual property, and the development of a product release plan. PUBLIC HEALTH RELEVANCE: Many cancers in the abdomen are best treated by surgical removal. The novel image guidance system being developed and demonstrated in this program has the potential to improve the precision and speed of today's minimally invasive techniques, while simultaneously reducing trauma to the patient. The technique may also improve the quality of invasive diagnostic tests and the staging of cancer t reatment.

* information listed above is at the time of submission.

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