This Small Business Innovation Research Phase I project for Information and Communication Technology aims to develop a workstation for the characterization of breast lesions on MRI to assist in breast cancer diagnosis. The specific aims of this SBIR proposal are: 1) to acquire and expand a breast lesion MRI database and, 2) to develop and document a workstation to follow FDA submission requirements.
In the US alone, 1 out of 8 women will be diagnosed with breast cancer during their lifetime. Proper diagnosis is a critical component of improving patient outcomes. In particular, earlier diagnosis can result in smaller surgical resections and may obviate the need for adjuvant radio- or chemotherapy. Over the past decade, the use of MRI for breast cancer screening and diagnosis has been rapidly expanding due to its notably higher sensitivity over traditional methods such as mammography. As the data from MRI scans consist of over 300 high-resolution images, this migration presents an increasingly difficult and time-consuming challenge for radiologists. The interpretive challenge presented by the data-intense nature of MRI is only compounded when considering that a malignant lesion may present as only a small speck (~0.5 mm) on a single image. The effort aims to extract relevant information from the rich dataset and improve the efficiency, accuracy, and consistency of image interpretation. The proposed analysis and interpretation techniques include automatic lesion segmentation, automatic image information extraction, and intelligent information fusion.
? Quantitative Insights successfully translated a transformative, next generation computer-aided diagnostic software platform to expedite and enhance breast cancer analysis from dynamic, contrast enhanced magnetic resonance images (MRI), from an academic to industrial setting. Prior to translation, the software platform’s effectiveness had been clearly illustrated in a clinical setting, and illustrated substantial improvements in diagnostic performance, which will positively impact the patient through reducing missed cases of cancer and in turn reducing the morbidity and mortality associated with breast cancer and leading to noteworthy reductions in healthcare expenditure. The software platform, called QuantX, was initially developed at the University of Chicago, but suffered from a variety of issues that would prevent it from positively impacting clinical outcomes – namely, the coding did not adhere to FDA guidelines, and consequently, could not be legally sold, and the user interface was not developed and refined with the intent of commercialization. Work within the Phase 1 grant period sought to actively alleviate these problems and to function as an essential step in the path toward commercialization. The principal work within the grant period included: 1. Complete recoding of the QuantX platform and incorporation of feedback from expert clinical consultants to ensure that the features associated with the QuantX platform, including work environment, software structure, and documentation, strictly adhered to FDA guidelines. 2. Elicitation of advice and feedback from Key Opinion Leaders in radiology, including Dr. Gillian Newstead, to help refine the user experience and in turn facilitate rapid adoption of the QuantX platform upon obtaining clearance/approval from the FDA.
