Use of High-Resolution Microendoscopy (HRME) in Patients With Cervical Dysplasia
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Concordance Between the Diagnosis Using HRME Imaging and the Most Severe Histologic Diagnosis ( Concordance rate monitored using method described by Thall et al. (1995))
研究概览
简要总结
The goal of this clinical research study is to compare a type of imaging called high-resolution microendoscopy (HRME) for detecting abnormal tissue in the cervix to the standard of care, which is visual inspection with acetic acid (VIA) with a colposcopy procedure. Researchers also want to learn if HRME images can show the difference between cancerous tissue and normal cervical tissue.
详细描述
If you are found to be eligible to take part in this study, you will first have your scheduled VIA and colposcopy. The study doctor will tell you more about this procedure.
You will then have proflavine hemisulfate solution (contrast dye) applied to your cervix. Images will be collected with the probe from the HRME device. The HRME probe is a long thin tube with a camera at the tip. This should add about 10 minutes to the total procedure time.
The HRME images will be stored in an electronic database and used for research. The images will be deidentified and only the MD Anderson staff will have access. This data will be stored in the database indefinitely (forever).
Any abnormal areas found during the VIA and/or colposcopy will be biopsied as part of your standard of care using very small forceps (a medical tool that is like tongs). If the exam shows no abnormalities, a normal area will be biopsied.
The study doctor will talk to you about the results of the HRME imaging, colposcopy, and biopsy/ies.
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
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women undergoing colposcopy for an abnormal Pap test, positive HPV test or history of cervical dysplasia (CIN or AIS)
- •Women of childbearing potential must have a negative pregnancy test
- •Women who are at least 21 years of age or older
- •Ability to understand and the willingness to provide informed consent and sign a written Informed Consent Document (ICD)
排除标准
- •Women < 21 years of age
- •Women with a known allergy to proflavine or acriflavine
- •Women who are pregnant or nursing
- •Patients unable or unwilling to provide informed consent or sign a written Informed Consent Document (ICD)
研究组 & 干预措施
High-Resolution Microendoscopy (HRME) + Colposcopy
Visual inspection of cervix performed using 3 - 5% acetic acid to the cervix. Participants undergo standard colposcopy and abnormal lesions noted by quadrant. Then 0.01% proflavine applied topically to the cervix. High-resolution microendoscopy (HRME) then performed. HRME images obtained from one visually normal site and from up to 3 visually abnormal lesions based on visual exam and/or colposcopic findings. Study staff follow up with participant by phone one month after procedure.
干预措施: Proflavine (Drug)
High-Resolution Microendoscopy (HRME) + Colposcopy
Visual inspection of cervix performed using 3 - 5% acetic acid to the cervix. Participants undergo standard colposcopy and abnormal lesions noted by quadrant. Then 0.01% proflavine applied topically to the cervix. High-resolution microendoscopy (HRME) then performed. HRME images obtained from one visually normal site and from up to 3 visually abnormal lesions based on visual exam and/or colposcopic findings. Study staff follow up with participant by phone one month after procedure.
干预措施: HRME Imaging (Device)
High-Resolution Microendoscopy (HRME) + Colposcopy
Visual inspection of cervix performed using 3 - 5% acetic acid to the cervix. Participants undergo standard colposcopy and abnormal lesions noted by quadrant. Then 0.01% proflavine applied topically to the cervix. High-resolution microendoscopy (HRME) then performed. HRME images obtained from one visually normal site and from up to 3 visually abnormal lesions based on visual exam and/or colposcopic findings. Study staff follow up with participant by phone one month after procedure.
干预措施: Phone Call (Behavioral)
High-Resolution Microendoscopy (HRME) + Colposcopy
Visual inspection of cervix performed using 3 - 5% acetic acid to the cervix. Participants undergo standard colposcopy and abnormal lesions noted by quadrant. Then 0.01% proflavine applied topically to the cervix. High-resolution microendoscopy (HRME) then performed. HRME images obtained from one visually normal site and from up to 3 visually abnormal lesions based on visual exam and/or colposcopic findings. Study staff follow up with participant by phone one month after procedure.
干预措施: Colposcopy (Procedure)
High-Resolution Microendoscopy (HRME) + Colposcopy
Visual inspection of cervix performed using 3 - 5% acetic acid to the cervix. Participants undergo standard colposcopy and abnormal lesions noted by quadrant. Then 0.01% proflavine applied topically to the cervix. High-resolution microendoscopy (HRME) then performed. HRME images obtained from one visually normal site and from up to 3 visually abnormal lesions based on visual exam and/or colposcopic findings. Study staff follow up with participant by phone one month after procedure.
干预措施: Acetic Acid (Drug)
结局指标
主要结局
Concordance Between the Diagnosis Using HRME Imaging and the Most Severe Histologic Diagnosis ( Concordance rate monitored using method described by Thall et al. (1995))
时间窗: 1 day
To evaluate the performance of HRME imaging compared with existing diagnostic techniques including colposcopy and visual inspection with acetic acid (VIA), a successful outcome is defined as concordance between the diagnosis using HRME imaging and the most severe histologic diagnosis. That is, researchers will calculate the concordance with the participant as the experimental unit rather than the biopsy, as each participant may have more than 1 biopsy. Target concordance rate is 70%. Concordance rate monitored using method described by Thall et al. (1995), and trial stopped if concordance rate is less than 70%.
次要结局
未报告次要终点