Ex Vivo Multimodal Imaging of Upper Aerodigestive Epithelium
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Accuracy and Interrater Reliability of HRME Image Interpretation
研究概览
简要总结
The purpose of this research study is to collect information on whether images made using investigational microscopes can improve researchers' ability to evaluate and distinguish between normal and abnormal areas in tissue samples surgically removed from patients with squamous cell carcinoma. The microscopes being used in this study are considered investigational because they have not been approved by the United States Food and Drug Administration (FDA) for finding abnormal or pre-cancerous areas.
详细描述
The overall objective of this exploratory study is to evaluate whether noninvasive fluorescence and reflectance imaging of the upper aerodigestive tract can help clinicians more accurately determine intraoperative margins during ablative cancer surgery. This is an ex vivo study designed to evaluate the feasibility of using prototype optical imaging technology to enhance the discrimination between areas of noncancerous "normal" and cancerous mucosa. The results of this laboratory study will be used to further refine and develop this technology for in vivo application.
Primary Aim:
(1) To collect data to develop imaging algorithms to distinguish between normal and cancerous upper aerodigestive mucosa.
Secondary Aims:
- To compare the combination of wide-field fluorescence/reflectance and high resolution fluorescence microscopy images of upper aerodigestive epithelium to histopathologic analysis of biopsied tissue.
- To compare the ability of sequential wide-field/fluorescence microscopy imaging to discriminate between normal and cancerous oral cavity mucosa with that of white-light images obtained after staining with toluidine blue.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with biopsy-proven squamous cell carcinoma of the oral cavity, oropharynx, larynx, and/or hypopharynx.
- •Must be receiving surgical treatment for their cancer.
排除标准
- •Presence of medical or psychiatric condition affecting ability to give voluntary, informed consent.
结局指标
主要结局
Accuracy and Interrater Reliability of HRME Image Interpretation
时间窗: baseline
We will ask blinded raters to classify the HRME images as either benign (normal) or dysplastic/cancerous (abnormal)
次要结局
未报告次要终点