Laryngeal carcinoma is the most common primary head and neck malignancy. Flexible fiber-optic or rigid endoscopes are normally inserted through the nose or into the pharynx for conventional physical examinations, but endoscopy alone cannot be used to differentiate between benign, pre-malignant and early malignant lesions, which are characterized by identical symptoms such as throat pain, coughing, or hoarseness, and nearly identical physical appearance. Both conventional examination and endoscopy lack the ability to visualize the depth of penetration of disease into the deeper layers of the tissue, and provide information on vocal fold epithelial structure. Therefore, laryngeal cancer diagnosis has to rely on biopsies, which requires general anesthesia and surgical endoscopy. Multiple and repeated biopsies are common in order to increase diagnostic yield, and with this increasing morbidity form surgery. Regardless of the toll exacted on patients and their families, there are major costs associated with surgery, and significant patient time away from work. Hence, there is a huge need to develop a fast, mobile and noninvasive technology to aid in the early detection and monitoring of laryngeal malignant lesions, assist in selecting patients to undergo surgical biopsy. The use of OCT in managing early laryngeal epithelial cancer will be analogous to the use of macroscopic imaging modalities (i.e., MR, CT) in managing large solid tumors in the body. Using several licensed patents, OCT Medical Imaging Inc. (OCTMI) proposes to address the treatment and diagnosis of early laryngeal cancer using light based fiber optic imaging technology known as optical Coherence tomography (OCT), which produces a cross- sectional images at near histopathological resolution(Fujimoto 2000). The first in vivo endoscopic OCT images in animals and humans were reported in 1997 (Tearney, 1997)). Many clinical applications require a large area or 3-D imaging, which is difficult to achieve with the Time Domain (TD) OCT. Hence, OCTMI proposes to use advanced Fourier domain (FD) OCT technology which provides 3D imaging at high speed and sensitivity ( Leitgeb, 2003). Second, the paradigm shift from OR based to office-based imaging is necessary to make OCT a useful technology for head and neck cancer screening, early detection, and monitoring of disease progression. Incorporating this technology, OCTMI proposes to develop an advanced compact, cost-effective office based real-time 3D-functional Fourier domain functional OCT system that will not only acquire images at near histopathological resolution, but also will provide clinically important structural information on suspect lesions, potential biopsy sites, and cancer margins of larynx in the office without the need for general anesthesia or sedation. OCTMI is well positioned to develop this technology since its founders and collaborators have developed several office-based real-time 3D-OCT systems and were first to conduct large scale clinical trials on laryngeal cancer to the best of our knowledge

Public Health Relevance

OCTMI is seeking funds that will directly contribute to the easy advanced detection and diagnosis of laryngeal cancer. We are seeking funds from NCI to develop an advanced functional OCT system that will help reduce mortality, minimize number of invasive biopsies and dramatically improve the clinical outcome, while reducing cost and time required for diagnosis. Proposed office based system is not only similar to the system already tested ex-vivo, but also tested in human clinical trials at the UCI labs. OCTMI has licensed OCT technology from University of California, Irvine. Researchers and clinician who participated in system development and clinical trials are either co-founders of OCTMI or collaborating in this project. Out technology which was developed in the laboratory is now being transferred to market place through OCTMI. Hence this proposal in ideal for PA-08-114 program. Public Health Relevance Statement Page 7

National Institute of Health (NIH)
National Cancer Institute (NCI)
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
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Special Emphasis Panel (ZRG1)
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Evans, Gregory
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Oct Medical Imaging, Inc.
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Coughlan, Carolyn A; Chou, Li-Dek; Jing, Joseph C et al. (2016) In vivo cross-sectional imaging of the phonating larynx using long-range Doppler optical coherence tomography. Sci Rep 6:22792