Alan Penn & Associates Inc — Department of Health and Human Services SBIR Phase II: 102

Description

DESCRIPTION provided by applicant Diffusion Weighted Imaging DWI has the potential for being a safe cost effective alternative to ultrasound as a supplemental procedure to mammography for screening the of women with dense breasts to identify women who have suspicious breasts lesions The investigators have developed two patent pending methods for improving sensitivity in detection of breast cancer using DWI Analyzing ADC gradient at the lesion border and Enhancing diffusion images to improve differentiation of lesion from background tissue In the Phase I study the novel methodologies successfully detected and discriminated a high percentage of breast lesions without rejecting any cases because of imaging problems or patient motion In Phase II the investigators will develop a prototype computer aided diagnosis CAD system using the novel methodologies and will evaluate performance with a reader study The primary measurement for detecting breast cancer in DWI is Apparent Diffusion Coefficient ADC Other measures of diffusion require Diffusion Tensor Imaging DTI an imaging procedure that takes twice as long as DWI and is more difficult to cost justify Using standard methodologies ADC has two critical shortcomings low sensitivity and high rejection rate due to imaging problems and patient motion which hinder clinical use of DWI for breast cancer detection The two innovative methodologies developed in Phase I improved sensitivity and had zero rejection rate in the Phase I feasibility study Both mammography and ultrasound miss a significant percentage of breast cancers in women with dense breasts Dynamic Contrast Enhanced DCE MRI screening has high sensitivity but is not recommended for screening women who have a low or moderate risk of breast cancer The American Cancer Society recommends DCE for breast cancer screening when a womenandapos s risk is higher than a threshold that is not met when high breast density is the only risk factor The long range goal of this project is to develop a clinically and commercially viable CAD system for evaluating DWI images which when used in conjunction with mammography is able to identify those women with dense breasts who have a breast cancer risk greater than the ACS threshold for which follow up DCE screening is cost justified PUBLIC HEALTH RELEVANCE A significant percentage of breast cancers are currently missed in the of women with dense breasts when screening is performed with mammography and ultrasound the current standard of care The proposed research investigates the use of innovative technology to improve the sensitivity of diffusion weighted imaging as a supplement to digital mammography in the detection of breast cancer in women with dense breasts