SBIR-STTR Award

Mammography currently is the screening device for breast examination, although the false-positive rate in it could be 66% or higher. Thus imaging ultrasound and biopsy must often be used for final diagnosis. However, ultrasound has potential for improved spatial resolution, and could provide features that mammography currently does not have: real- time viewing, 3-D imaging, absence of ionizing radiation, and characterization of mechanical properties of the tissue, which we propose to exploit with an advanced ultrasound scanner design. We propose the development of a new technology that will yield an operator-independent, very high-resolution, real-time imager with 3-D imaging capabilities. Our approach is to use a Phase I grant to determine the trade-offs in various methods for applying low F-number 1.5-D arrays with center frequencies of 5 MHz (or higher). Our methods will include B-scan, synthetic focusing with and without corrections for time of flight, and adaptive focusing using a maximum brightness method. The Phase I project will use an existing laboratory scanner to develop the trade-offs for the various methods for the construction of a clinical prototype scanner in Phase II. PROPOSED COMMERCIAL APPLICATIONS: This proposal will lead to a significant advancement in noninvasive breast cancer screening with non-ionizing ultrasound. It is expected to provide a scanner with higher sensitivity (more suitable to cancer screening) and with lower false positivities (fewer biopsies) and be a strong competitor in a potential billion dollar cancer screening market.

Thesaurus Terms:
biomedical equipment development, breast neoplasm /cancer diagnosis, clinical biomedical equipment, computer simulation, noninvasive diagnosis, ultrasound scanning computer program /software, diagnosis design /evaluation, phantom model bioengineering /biomedical engineering

Mammography is currently the screening device for breast examination, even though its false-positive rate may be 66% or higher. Thus ultrasound imaging and biopsy must often be used for final diagnosis. However, ultrasound has the potential for improved spatial resolution can provide additional features (currently not available in mammography) to aid in cancer diagnosis such as characterization of the mechanical properties of tissue, 3-D imaging, no ionizing radiation, real-time viewing and improved patient comfort. We intend to demonstrate these advantages with a clinical prototype scanner. TechniScan will design, build and test an advanced clinical prototype ultrasound scanner which will be operator independent, have 3-D capabilities, feature the highest reflection resolution for a given element bandwidth, use multistatic excitation for maximal contrast resolution and perhaps most significantly feature 2 wavelength (0.6 mm at 5 MHz) quantitative images of speed of sound and attenuation. This clinical prototype scanner is expected to demonstrate the advantages of high resolution 3-D ultrasound reflectivity and inverse scattering images to such a high degree that TechniScan can readily develop the funding to produce commercial scanners. PROPOSED COMMERCIAL APPLICATIONS: This proposal will lead to a significant advancement in noninvasive breast cancer screening with non-ionizing ultrasound. It is expected to provide a scanner with higher sensitivity (more suitable to cancer screening) and with lower false positivities (fewer biopsies) and be a strong competitor in a potential billion dollar cancer screening market.

Thesaurus Terms:
biomedical equipment development, breast neoplasm /cancer diagnosis, clinical biomedical equipment, computer simulation, noninvasive diagnosis, ultrasound scanning computer program /software, diagnosis design /evaluation, phantom model bioengineering /biomedical engineering, bioimaging /biomedical imaging, clinical research, female, human subject