EFRI-BioFlex: Miniature, low-cost fiber-optics technology for measurement of tissue structure at sub-diffractional length scales: a platform for cancer screening

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This project is at the interface of biophotonics, electronics and computational electrodynamics with applications to medicine. The main thrust is the development of a principally new disposable, low-cost, miniature fiber-optics probe technology that would enable minimally or non-invasive population screening for major cancers while being comfortable to patients, enabling a major improvement in diagnostic accuracy, and reducing health care costs. Intellectual Merit: From the engineering perspective, the key areas of innovation are biophotonics and computational electromagnetics. The underlying biophotonics technology is Low-coherence Enhanced Backscattering Spectroscopy. The major technological advantages are miniaturization and the ability to depth-selectively quantify sub-diffractional (down to a few tens of nanometers) structure of live tissue, which is impossible with existing endoscopic or fiber-optic tools. In its application to cancer screening, the proposed approach takes advantage of the concept of field carcinogenesis, the notion that, initially, molecular/nanostructural alterations develop diffusely throughout an affected organ while further stochastic mutations lead to focal tumors. Thus, a cancer risk can be assessed by non-invasive analysis of tissue ultrastructure from an easily accessible surrogate site, such as the rectum for colon cancer, cheek mucosa for lung cancer, duodenal mucosa for pancreatic cancer, endocervix for ovarian cancer, etc. The project has three aims: (1) Development of a new paradigm for linking the ultrastructural and optical properties of tissue based on the Finite-Difference Time-Domain modeling of light-tissue interactions with nanoscale detail. Stochastic Finite-Difference Time-Domain simulation, a principally new approach to numerically solving Maxwell?s equations and modeling light transport in tissue of arbitrary complexity, will be developed. (2) Development of the miniature Low-coherence Enhanced Backscattering Spectroscopy probe. The design is a radical departure from other fiber-optics probes currently under development for biomedical applications, leveraging micro- and nano-fabrication technology and new sub-millimeter image sensors to produce an integrated device with unprecedented compactness capable of fully resolving the enhanced backscattering peak, and in turn, quantifying nanostructural changes in tissue. (3) Pilot human studies to demonstrate the potential clinical impact of the technology. Broader Impact:Although it is well accepted that cancer screening can dramatically decrease cancer mortality, no population screening exists for the majority of cancers. This is because existing techniques require examination of already formed cancerous or pre-cancerous lesions through interventional procedures (colonoscopy, endoscopy, bronchoscopy, etc.) and suffer from some of the following drawbacks: invasiveness, expense, low patient tolerance, or low sensitivity to curable lesions. The proposed technology may lead to a new paradigm in cancer screening that would be applicable to essentially any major cancer type and, due to its low-cost and high patient tolerance, can actually be used in the entire population. Furthermore, the implementation of the technology has the potential to dramatically reduce health care costs by identifying early preventable neoplastic lesions or early, readily treatable cancers. The project will also help increase the exposure of middle and high school students from underrepresented minority groups and inner-city schools to engineering, science and technology.