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临床试验/NCT02722395
NCT02722395已完成不适用

Magnetic Resonance Imaging (MRI) Solely For Liver Stereotactic Body Radiation Therapy (SBRT)

Duke University1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2016年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
5
试验地点
1
主要终点
Image quality, as measured by tumor-to-live contrast to noise ratio

研究概览

简要总结

This study is a research and development initiative established to explore the use of magnetic resonance imaging (MRI) as a tool for managing organ motion of the liver in cancer patients planning procedures for stereotactic body radiation therapy (SBRT).

详细描述

There is a potential role to systematically implement MRI to establish appropriate workflow of the implementation for tumor motion management in liver SBRT. Compared to CT, MRI has many significant advantages for radiotherapy planning, including superior tumor and soft-tissue contrast, flexible imaging orientation, freedom from radiation exposure and real-time imaging. MRI solely based liver SBRT will allow for more precise delineation of target volume, less uncertainties in treatment planning, better motion management, and potentially better treatment outcome

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with primary stage I, II, III liver cancer or metastatic tumor in the liver from any cancer site
  • Signed, specific informed consent prior to study entry
  • Women of child bearing potential must have a negative serum pregnancy test

排除标准

  • Any condition for which a MRI procedure is contraindicated including presence of metallic material in the body, such as pacemakers, non- MRI compatible surgical clips, shrapnel.
  • Pregnant or breast-feeding women are excluded.
  • Subjects who have difficulty lying flat on their back for extended periods of time

结局指标

主要结局

Image quality, as measured by tumor-to-live contrast to noise ratio

时间窗: During MRI approx 1 hour

Image quality, as measured by image rating

时间窗: During MRI approx 1 hour

Image quality will be measured on a scale of 1 to 5, 1 being the best.

Measure average motion trajectories

时间窗: During MRI approx 1 hour

Image quality, as measured by tumor volume

时间窗: During MRI approx 1 hour

Planning target volume (PTV)

时间窗: During MRI approx 1 hour

PTV is defined as PTV=internal target volume (ITV) + safety margin (M)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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