BIOPSY NEEDLE FOR TUMOR BLOOD FLOW QUANTIFICATION

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This project seeks to incorporate blood flow (perfusion) sensors with core and aspiration biopsy needles. The feasibility of the integrated device was unambiguously demonstrated and validated in Phase I using the gold- standard microsphere technique in vivo. This device (needle, sensor, instrument and software) will serve as a tool to investigate the relationship between tumor blood flow/oxygenation and anti-tumor therapy outcome. Since perfusion is the carrier of oxygen which is a modifier of radiotherapy and chemotherapy, perfusion plays a significant role in the outcome of these therapies. There does not exist a tool to routinely assess tumor perfusion. This low cost device will provide information about the success of tumor blood flow modification agents, to help plan anti-tumor therapy for maximal effectiveness and to ensure that the biopsy is taken from diagnostic, non- necrotic tissue. Also it will collect perfusion data without increased patient morbidity nor increased risk for seeding the normal surrounding tissue with tumor cells over that of a standard biopsy procedure. In Phase II, biopsy perfusion probes will be designed and developed along with the controlling electronics and data analysis algorithms for use in a stand- alone computer/instrument. This entire system will be validated in a tumor model against the microsphere technique and the ability to modify tumor blood flow will be quantified. PROPOSED COMMERCIAL APPLICATION: The instrumented biopsy needle for the measurement of tumor blood flow has the potential to predict the efficacy of non-surgical anti-tumor therapy for hundreds of thousands of patients in the US each year. This device should find wide application in many research centers studying tumor blood flow in animal models and humans. A low-cost biopsy needle adjunct which quantifies tissue viability and tissue ischemia, and permits sensing of vessels in close proximity to the needle tip to aid in navigation, is expected to have great commercial potential.