3D Image-guided Intracavitary Brachytherapy Treatment Planning for Cervical Cancer Using a Novel Shielded Applicator
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Number of Participants With Improved Image Quality in the Shifted Position
研究概览
简要总结
The goal of this clinical research study is to learn if computed tomography (CT) and magnetic resonance imaging (MRI) images can better help to plan internal radiation treatment.
详细描述
Treatment planning for patients with cervical cancer treated at MD Anderson is usually performed based on x-ray films taken while the patient is under anesthesia in the operating room. In this study, you will have an MRI and CT scan performed after recovering from anesthesia in addition to the standard x-rays. In order to allow MRI images to be taken, special MRI compatible applicators will be used. The CT and MRI images will be reviewed by the doctor in charge of radiation treatment and will also be used for research purposes.
Study Procedures:
If you agree to take part in this study, an applicator made of a material that can be used during an MRI will be used.
You will have a CT scan and an MRI scan performed after the implant is placed in the operating room. The CT scan should take about 20 minutes and the MRI about 55 minutes. These scans will be performed after you wake up from general anesthesia. Pain medicine will be given if you feel any discomfort from the placement of the implant.
The additional scans will be used to confirm appropriate placement of the applicator and may result in small adjustments to your radiation treatment plan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Women with stage greater than or equal to IB2 cervical cancer treated with definitive chemoradiation or radiation therapy who require intracavitary brachytherapy.
排除标准
- •Patient or tumor anatomy that requires use of a non-MRI-compatible applicator.
- •Patients who require interstitial brachytherapy.
- •Patients whose treating physician feels that they require additional 3D imaging at the time of implant based on physical exam or initial findings.
- •Patients with implantable cardioverter-defibrillator, pacemaker or other implanted device, which precludes MRI acquisition.
结局指标
主要结局
Number of Participants With Improved Image Quality in the Shifted Position
时间窗: At the time of implant
To determine the number of participants with improved image quality using the Novel Brachytherapy Applicator, using subjective and objective measures. In the subjective, for assessment of image quality for clinical use, the images obtained in the "shifted" position and in the "standard" position, were compared by a radiation oncologist without knowledge of which was the first and which was the second image. To provide and objective measure of the reduction in image artifact with the shields shifted, the bladder, rectum, and sigmoid were contoured, and average and standard deviation of Hounsfield units (HU) within these critical structures on the images were compared.
次要结局
- Number of Participants With High Quality Images With the Adaptive Applicator in the Shifted or Standard Position(At the time of implant)