Development of the Standard for Clinical Breast Perfusion Imaging

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Department of Health and Human Services
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Phase I
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Socially and Economically Disadvantaged:
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Phone: (262) 780-6487
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DESCRIPTION (provided by applicant): Currently detection of breast tumors is most often accomplished with x-ray mammography. This is true despite the fact that mammography misses 5-15% of palpable breast cancers and has a positive predictive value of only 15-30%. Consequently, mammography requires a much higher rate of biopsy than occurrences of malignancy. Alternatively, contrast-enhanced magnetic resonance imaging (MRI) has been shown to be highly sensitive for breast cancer. However, these benefits are o ffset by the fact that it too has frequent false positive findings, and has therefore not been routinely adopted. More recently, T1-weighted dynamic contrast- enhanced magnetic resonance imaging (DCE-MRI) combined with two-compartment pharmacokinetic model ing has demonstrated potential for better differentiating benign from malignant tumors. Still, these DCE methods have not had the impact on specificity as originally hoped. This has been attributed to the fact that the indices derived from the DCE approach , such as Ktrans, the plasma-tissue contrast agent transfer constant, are influenced by several factors together including blood volume, flow and vascular permeability, often making interpretation difficult and thus sub-optimal for distinguishing benign fr om malignant lesions. Consequently, we propose an alternative dynamic-contrast method, which directly measures tumor blood volume and other vascular parameters individually, as a way to provide both specific and sensitive markers for breast cancer imagin g. The approach is based on T2*-weighted dynamic susceptibility contrast (DSC) MRI methods. The challenge with the DSC approach, and the reason why it has only rarely been used for perfusion measurements outside of the brain, is that it can be confounded b y T1 and T2/T2* changes, which occur when contrast agent leaks out of the vessels. Thus for DSC imaging to be feasible and meaningful for breast MR imaging, where Gd contrast agents readily leak out of the vessels, these confounding factors must be minimiz ed and/or corrected. In this regard, based on 10+ years of performing DSC studies in leaky brain tumors, and a recently study performed by us to compare several different DSC methods, we have developed what we hypothesize to be the complete solution to bre ast tumor perfusion imaging. The primary approach is to collect dual-echo spiral based data, which directly negates T1 effects, and then apply a post-processing algorithm to diminish T2 leakage effects. The additional advantage of this approach is that T1- weighted DCE data can be collected, from the first echo, at the same time. This novel combination of technologies is the basis for an invention disclosure, for which Imaging Biometrics LLC will have an exclusive license. It will form the foundation of Imag ing Biometric's initial MRI breast perfusion analysis product. Given the statistics of breast cancer and recent recommendations from the American Cancer Society (ACS), the commercial market potential and societal gain for this technology is outstanding. In the U.S. the incidence of breast cancer is approximately 240,000 in 2006 with a compounded annual growth rate of 4.1%. Each year 40,000 women die of breast cancer and one out of eight women will get breast cancer at some point in her lifetime. An estimate d 50 million MRI procedures will be performed in 2007 and 45% of those will involve a contrast agent. And just recently the ACS American Cancer Society (March 28, 2007) released new guidelines advising annual MRI screening for women with high lifetime risk of breast cancer, defined as 20% or more. Of the 70 million woman in the U.S. between 30 and 70 years of age, 1-1.5 million fall into one of the high risk groups recommended for routine screening with breast MRI, along with mammography. In response to the need for better and more specific MRI methods, and recent ACS recommendations, Imaging Biometrics LLC proposes to develop and market the novel DSC perfusio

* information listed above is at the time of submission.

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