KITWARE INC — Department of Health and Human Services SBIR Phase II: 102

Description

DESCRIPTION provided by applicant There are several features of ultrasound imaging that make it attractive to clinicians and preclinical researchers including its relatively low cost rel time imaging capability safety and portability For example ultrasound imaging is widely used for anatomical imaging and blood flow measurements in the heart and large vessels Ultrasound however is typically not used in oncology because it has relatively poor quantitative capability with respect to tumor morphology or malignancy In our Phase I work we demonstrated that our new contrast enhanced dual frequency ultrasound technologies andquot Acoustic Angiographyandquot can capture detailed in vivo images of tissue vasculature in animal models of breast cancer and we have shown that vascular morphology is an indicator of tumor malignancy in those animal models That work built upon our prior vessel analysis research and algorithms that showed that quantifiable vascular morphology metrics from Magnetic Resonance Imaging data are reliable predictors of tumor malignancy and response to therapy in humans In the proposed Phase II work we will conduct the research necessary for the commercialization of our acoustic angiography system for preclinical research The team has been expanded to include SonoVol the manufacturer of ultrasound systems for preclinical research We will research and evaluate methods to ensure that our commercial system will be easy to use and consistently produce effective measures of tumor malignancy and response to therapy We will validate the product in a blinded study of breast cancer treatment efficacy in support of a preclinical trial i e the targeted commercial use for the proposed system PUBLIC HEALTH RELEVANCE Ultrasound is a relatively safe low cost portable real time imaging device however its images are relatively poor for detecting and diagnosing tumors We propose that ultrasound can be extended to tumor assessment via a commercial system that combines new micro bubble contrast agents that enhance the appearance of vessels within ultrasound images with an ultrasound imaging probe that we developed for capturing contrast enhanced ultrasound images and with novel vascular image analysis algorithms that we have also developed In Phase I we showed that our system is viable In the proposed Phase II work we will conduct the research and development needed to commercialize that system for assessing tumor malignancy and response to treatment in support of preclinical trials of experimental cancer therapies