SBIR-STTR Award

The proposed research is intended to show the feasibility of developing a commercial ultrasound mammography system (nonionizing modality) with a detection ability similar to X-ray mammography systems (lesions 5 mm or less), and based on combined tissue and blood-flow imaging. The blood-flow imaging is significant, since malignant tumors exhibit dramatically increased vascularity and blood flow when measured with ultrasound Doppler. The instrument is intended for both screening and diagnosis.To overcome the limitations of conventional ultrasound mammography, several new imaging concepts will be evaluated. The received pulseecho ultrasound RF data of a full image will be digitized to greatly increase the flexibility of the software processing. The digital signal processing will produce both a tissue-structure image and a blood-flow image of the scanning plane. The negative pressure sensitivity of tumor blood flow will be investigated separately as a possible method of differentiating between benign and malignant lesions by use of a special scanning tank. This scanning tank design will also permit its use with the patient in a sitting or standing position. For evaluation of the mammography system, ultrasound scanning of normal volunteers and women with diagnosed breast cancer is planned.National Cancer Institute (NCI)

The research is intended to develop a prototype of an automated commercial ultrasound mammography system with a spatial resolution similar to x-ray mammography systems and based on combined tissue and blood flow imaging. The blood flow imaging is significant, since malignant tumors exhibit dramatic, locally increased vascularity and blood flow. The Doppler color flow mapping instrument is intended initially as an adjunct to X-ray mammography, but may also be used as a screening device. To overcome the limitations of conventional ultrasound mammography, the proposed work will include new imaging concepts.In the existing laboratory model completed under the Phase I grant, the received pulse-echo ultrasound RF data of a full image is digitized which gives greatly incresed flexibility of software processing. The digital signal processing produces both a tissue structure image and a blood flow image of the scanning plane. For evaluation of the mammography system, ultrasound scanning of normal volunteers at different times through the menstrual cycle, and of women with diagnosed breast cancer is planned. Images will be generated using different standard and proprietary algorithms off line, for comparison with surgical and histological finding to determine optimal processing methods. This work will begin in the firs year.In the second year a marketable prototype will be developed for real-time clinical use. This approach will allow all patient data to be processed with the same algorithms so that most up-to-date processing can be used on the entire data set. The clinical instrument prototype will be able to us the technology current at the end of this clinical series, instead of that available at the start, and thus reduce costs and avoid technological obsolescence.National Cancer Institute (NCI)