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Bimodal Intraoral imaging device for detection of oral epithelial neoplasia

用于检测口腔上皮瘤变的双模口内成像装置

基本信息

批准号：
9917503
负责人：
Xingde Li
金额：
$ 62.5万
依托单位：
UNIVERSITY OF TEXAS MED BR GALVESTON
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-12-01 至 2024-11-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9917503
关键词：
Address Affect Agreement Animal Model Animals Area Biochemical Biopsy Cancer Etiology Carcinoma Cervix Uteri Clinic Clinical Coupled Detection Development Devices Diagnostic Early Diagnosis Early identification Early treatment Engineering Epithelial Epithelium Evaluation Excision Eye Feedback Fluorescence Generations Goals Histology Histopathology Human Human Papillomavirus Image Imaging Device Incidence Intraepithelial Neoplasia Knowledge Label Lesion Light Malignant Neoplasms Malignant neoplasm of cervix uteri Measures Metabolic Methodology Methods Microscopic Microscopy Molecular Morbidity - disease rate Morphology Mucous Membrane Neoplasms Operative Surgical Procedures Optical Biopsy Optics Oral Oral cavity Oral mucous membrane structure Oropharyngeal Oropharyngeal Squamous Cell Carcinoma Outcome Outcomes Research Palpation Pathology Patient-Focused Outcomes Patients Performance Pilot Projects Recurrence Recurrent disease Resolution Robotics Sampling Sampling Studies Screening for Oral Cancer Sensitivity and Specificity Site Specificity Spectrum Analysis Surface Survival Rate Testing Tissues Translating Treatment outcome Visual base cellular imaging clinical translation high risk human imaging human tissue imaging biomarker imaging capabilities improved in vivo in vivo imaging instrument malignant mouth neoplasm malignant oropharynx neoplasm microscopic imaging molecular imaging mortality neoplastic non-invasive imaging novel oral cavity epithelium performance tests pre-clinical preclinical study public health relevance screening second harmonic

项目摘要

ABSTRACT The goal of this project is to develop a novel bimodal intraoral imaging device for assessment of the oral and oropharynx mucosa for detection of neoplasia, aiding in early detection. Oral and oropharyngeal cancers account for 640,000 new cases of cancer worldwide each year. The number of cases increases each year, in part due to the spread of human papillomavirus. The 5-year survival rate has remained relatively unchanged over several decades, despite accessibility of the oral cavity and oropharynx for examination. With early detection, the 5-year survival rate increases to 80%, providing hope of improved patient outcomes given development of effective early detection approaches. The current clinical approach of detection by visual examination with palpation to guide biopsy acquisition, is insufficient to reliably detect neoplasia at the earliest, most treatable stages, including oral epithelial dysplasia (OED) and early oral/oropharyngeal squamous cell carcinoma (OSCC). Our preclinical and pilot clinical sample studies indicate that label-free nonlinear optical microscopy (NLOM), consisting of multiphoton autofluorescence microscopy and second harmonic generation, is highly promising as an optical biopsy method. It provides deep mucosal imaging at subcellular resolution and detects parameters associated with neoplasia that parallel histology. In addition to optical histology, NLOM provides additional spectroscopic metrics based on the metabolic and biochemical microenvironment, which may add to optical histology metrics. Our results assessing NLOM for this application show high sensitivity and specificity for detection of neoplasia, and a high degree of agreement with histopathology. Despite these advantages, a limitation of microscopy is the inherently limited image field of view on the order of hundreds of microns. On the other hand, clinical large area screening methods comprised of widefield autofluorescence (WF) imaging provide the fields needed (centimeters) with high sensitivity for detection, but lack specificity and cannot image below the surface or assess microscopic features. In this project, we will combine the benefits of both approaches into a single handheld intraoral imaging device that will provide large area screening for regions of suspicion for neoplasia using WF coupled with detailed, depth-resolved subsurface imaging by NLOM for highly sensitive and specific detection of high risk lesions (OED) and early OSCC. To accomplish this goal we will 1) construct a biomodal WF-NLOM intraoral imaging device and optimize performance and suitability for noninvasive evaluation of neoplasia in human oral/oropharyngeal mucosa; 2) refine and translate methodology and metrics defined in preclinical studies, to the intraoral device for use in human OSCC; and 3) evaluate the bimodal intraoral imaging device performance and conduct a pilot study to evaluate the device in patients in vivo, obtaining valuable feedback regarding potential for detection of neoplasia and adaptability for the clinic.

摘要