Magnetic Resonance Imaging of Gynecologic Malignancies Involving the Vagina
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Accuracy of Tumor Involvement Detection
研究概览
简要总结
The goal of this clinical research study is to learn if a type of MRI scan called diffusion weighted imaging (DWI) is accurate in checking the status of tumors. Researchers also want to learn if DWI can predict how tumors will respond to radiation therapy.
详细描述
If you agree to take part in this study, information will be collected from your medical record including your age, sex, and status of the disease.
For the MRI scans, you will receive a routine contrast drug by vein. Contrast drugs are used by doctors in order to see MRI images more clearly.
A modified MRI scan will performed right after your scheduled standard-of-care MRI scan. This modified MRI scan is the investigational scan. To complete the modified MRI scan, you will need to stay in the MRI scanner for about 8 extra minutes. It should take about 47 minutes total to complete both scans.
The way that researchers program the MRI machine and the order in which the images are taken is what is being modified for the investigational scan. These changes may help researchers capture better images.
Length of Study:
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All patients who have gynecologic malignancies involving the middle third and the distal third of the vagina who will be receiving radiation therapy
- •Patients who have gynecologic malignancies involving the upper, middle and/or lower third of the vagina or are undergoing pelvic exenteration.
排除标准
- •Pregnant patients
- •Any implantable medical device that is not MRI compatible (e.g. pacemakers, defibrillators, pain pumps or insulin pumps)
结局指标
主要结局
Accuracy of Tumor Involvement Detection
时间窗: 1 day
Location of tumor involvement determined based on pre-treatment imaging findings, where inferior margin of tumor marked on the MRI. Tumor involved areas will then be evaluated by EUA, where fiducial markers will be placed and MRI images will be fused with the CT images to find if there is any discrepancy between the EUA and the DWI images. The primary endpoint is the accuracy of tumor involvement detection (binary endpoint), where tumor invasion is defined as similar to that seen by EUA, in the anterior/posterior or the lateral walls of the vagina. Similarity will be defined as the tumor margin seen on MRI being similar to what is seen on the EUA where the markers correspond to the margins defined on the MRI. This will be defined as 5mm or less.
次要结局
- Ability of Diffusion Weighted Magnetic Resonance Imaging (DWMR) to Assess Response to Radiation Therapy(4 weeks after radiation therapy treatment)