Reflectance Confocal Imaging of Cervical Intraepithelial Neoplasia (CIN)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 4
- 主要终点
- Reflectance confocal images of cervical tissue in vivo
研究概览
简要总结
The goal of this clinical research study is to see if reflectance confocal microscopy works as well as standard methods to detect cancer of the cervix or precancerous lesions.
Primary Objectives:
- To identify potential clinical advantages for a noninvasive method of diagnosing dysplasia and neoplasia in the cervix using reflectance confocal microscopy.
- To obtain real time reflected light images in vivo of sites in the human cervix.
- To access the effects of acetic acid as a contrast agent for in vivo reflectance confocal imaging.
- Evaluate the depth of penetration for the fiber optic confocal device and analyze the diagnostic value of images taken from different depths.
- Determine the sensitivity and specificity of this device for the diagnosis of CIN.
详细描述
Confocal microscopy may be a new way to detect lesions of the cervix quickly without removing a tissue sample. Women in the study will already be scheduled for colposcopy to detect or treat cervical lesions. (A colposcopy is an exam of the vagina and cervix using a magnifying lens.)
Microscopic images will be taken during the routine colposcopy in the outpatient clinic. A disinfected probe will be inserted into the vagina and placed against the cervix. . The probe sends out laser light and detects reflected light from the tissue. Images of cervical tissue will be formed and displayed on a computer monitor. 1-3 regions of the cervix will be imaged (2 abnormal and one normal), and each will take about 1-2 minutes.
Each imaged site will be biopsied. The biopsies will be analyzed by the research pathologist. The results will be available to participants in the event that care needs to be given. Total participation in this study will be only a few minutes.
This is an investigational study. About 72 women will take part in this study. About 18 will be enrolled at M. D. Anderson.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subjects will be individuals 18 years of age or older, who have voluntarily responded to advertisement in the form of posted flyers or word of mouth.
- •Subjects must sign an informed consent indicating awareness of the investigational nature of this study.
排除标准
- •Pregnant individuals will be ineligible for this study.
结局指标
主要结局
Reflectance confocal images of cervical tissue in vivo
时间窗: 1-2 minutes during routine colposcopy
次要结局
未报告次要终点