A Pilot Study: Measurement of Digital Colposcopy for Fluorescence Spectroscopy of Cervical Intraepithelial Neoplasia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 5
- 主要终点
- To study whether digital colposcopy for fluorescence (DCF) can perform better than standard methods to detect cancer of the cervix or precancerous lesions.
研究概览
简要总结
The overall objective of this study is to identify potential improvements for a noninvasive method of diagnosing dysplasia and neoplasia in the cervix using digital colposcopy for colposcopy for fluorescence spectroscopy.
Other Objectives:
- To measure digital fluorescence and reflectance images in vivo of sites in the human cervix.
- To evaluate the effect of acetic acid in the image contrast obtained.
- Compare the device performance to colposcopy and pathologic analysis of tissue removed at colposcopy.
详细描述
DCF may provide a better way to detect or treat lesions of the cervix. Women in the study will already be scheduled for colposcopy to detect or treat lesions of the cervix. (A colposcopy is an exam of the vagina and cervix using a magnifying lens).
DCF will be done during the routine colposcopy in the outpatient clinic. A digital colposcope (DC) device will be used to take a sequence of images of the cervix and vagina. (A DC is a digital camera connected to the colposcope with a specialized light source. It will shine light on the cervix and acquire a sequence images). The images will tell doctors about the cells and structure of the tissue. After the first set of images, acetic acid will be applied to the cervix so that lesions show up better, and 1-2 minutes later more readings will be taken.
Small samples of areas of abnormal tissue will be removed during colposcopy. Taking these tissue samples is a routine part of this type of exam. If patients are having colposcopy and loop electrosurgical excision procedure (LEEP treatment, one sample of normal tissue will be taken. (The cervix will be numbed for this procedure.) DCF images will be compared with lab findings from these samples. Before DCF is done, as standard of care, patients will have a complete history and physical exam, urine pregnancy test, pap smear, and cultures for gonorrhea, chlamydia and viral testing.
This is an investigational study. About 114 women will take part in this study. About 22 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
- •Women 18 and older with an abnormal Pap
排除标准
- •Pregnant individuals will be excluded from this study
结局指标
主要结局
To study whether digital colposcopy for fluorescence (DCF) can perform better than standard methods to detect cancer of the cervix or precancerous lesions.
时间窗: 7 Years
次要结局
未报告次要终点