Reflectance Confocal Microscopy of Oral Cancers in Vivo: a Preliminary Trial Comparing Intra-oral Imaging With Pathology
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 5
- 主要终点
- Reflectance Confocal Microscopy (RCM) images
研究概览
简要总结
The purpose of this study is to get images (pictures) of oral lesions, which occur inside the mouth, before the patient's surgery using a special camera. These pictures will be used in our research to evaluate a new technology that uses a laser and takes pictures of the microscopic structure of tissue. The technology is called "reflectance confocal microscopy." We would like to compare what the camera sees to biopsies (pathology) of the same area. We will evaluate the pictures obtained from the patient to determine whether this technology may be useful in the future. We hope this technology can be used as a tool for early diagnosis of oral cancers and for guiding surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients with biopsy-proven oral SCC who are scheduled to undergo surgery in the MSK Head and Neck Service.
- •Ability to sign informed consent.
- •Age ≥ 18 years.
排除标准
- •Cancer located on a site that may not be convenient or accessible for imaging with the current version of the RCM device (gingivobuccal region, back of the oral cavity, back of the tongue, floor of the mouth, deep under the tongue, etc.).
- •Inability to give informed consent.
研究组 & 干预措施
SCC of the oral cavity scheduled for surgery
The patients will be imaged for testing the feasibility of intra-oral imaging. Images will be compared to and evaluated against the corresponding pathology that is routinely prepared during surgery.
干预措施: Reflectance Confocal Microscopy (Device)
结局指标
主要结局
Reflectance Confocal Microscopy (RCM) images
时间窗: 1 year
Each set of images and the corresponding pathology will be evaluated by the study pathologist for the presence or absence of oral SCC. All images will be evaluated as a group. First, the pathologist will review the RCM images for each imaging site and will determine the presence/absence of tumor. Next, the pathologist will review the corresponding histopathologic material for the presence/absence of tumor. If there is discordance in the evaluations, the pathologist will re-evaluate the RCM images with the corresponding pathology, in a side-by-side manner, to highlight any features that may assist in the RCM evaluation.
次要结局
未报告次要终点