Optical Sensor for Photodynamic Detection of Oral Pathology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,004
- 试验地点
- 2
- 主要终点
- Healthy oral tissue
研究概览
简要总结
Overall objective of this work is to develop better ways of detecting, diagnosing and measuring oral diseases and structures using light and optical approaches. All different areas of the mouth will be imaged, including healthy, diseased, dysplastic and malignant, as well as oral biofilm, and the imaging data compared against conventional diagnostic approaches such clinical and histopathological and molecular evaluations to (1) gain a better understanding of processes involved in oral pathology and (2) develop a combined patient specific, non-invasive method for the detection, diagnosis and screening of oral pathology and biofilm. Thus our goal is to identify and evaluate microstructural, metabolic, vascular, protein, genomic and metabolomics biomarkers of oral pathology can be used to detect, predict and map oral pathology, especially neoplasia.
We are recruiting patients with a wide range of oral conditions including plaque, dry mouth, toothache, root canal treatments, gum disease, oral sores, dysplasia and cancer, autoimmune conditions and others as well as healthy control subjects. We will use a range of non-invasive imaging modalities to obtain information on the ways in which the oral health status affects optical properties, and determine means of detecting and quantifying these factors.. Imaging modalities to be utilized include:
- Coherence and Doppler Tomography
- Laser Speckle Imaging
- Various forms of Spectroscopy
- Fluorescence
详细描述
Purpose of the research is to identify optical predictors and biomarkers of health and disease.
Hypothesis
microstructural, metabolic, vascular, protein, genomic and metabolomics biomarkers of oral pathology can be used to detect, predict and map oral pathology, especially neoplasia.
Researchers of the Beckman Laser Institute (BLI) have developed many non-invasive imaging modalities for assessment of oral tissue. This protocol will allow data acquisition with these multiple modalities to allow validation of data. Imaging modalities to be utilized include:
- Coherence and Doppler Tomography (OCT)
- Laser Speckle Imaging (LSI)
- Photon Migration Spectroscopy (PMS)
- Autofluorescence Imaging
In addition, saliva samples from the patients will be analyzed and the resulting data regarding the dysregulation in the activities of genes, proteins and other molecules will be correlated with findings from different imaging systems with respect to the stage of oral carcinogenesis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
No masking other than an anonymization of data.
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or Female age 18 years and older
- •Have oral lesion or not have oral lesion
- •Have condition of dry mouth
- •Have condition of Gum disease
- •Non-smoker
排除标准
- •Age less than 18 years old
- •Advanced gum disease, diseases of oral tissue
- •Untreated cavities
- •Pregnant or breastfeeding
- •Immune compromised individuals
研究组 & 干预措施
Oral tissue
Imaging of oral structures and pathologies
干预措施: detection of oral pathology (Device)
结局指标
主要结局
Healthy oral tissue
时间窗: up to 12 months
Develop a non-invasive tool for the detection, diagnosis and screening of oral pathology and understanding of processes involved in oral pathology
次要结局
未报告次要终点
研究者
Petra E. Wilder-Smith
Professor of Surgery and Director of Dentistry
University of California, Irvine
