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临床试验/NCT02019199
NCT02019199已完成不适用

Magnetic Resonance Imaging ( MRI) for Radiation Therapy Treatment Planning Evaluation of Lung, Liver and Pancreatic Motion.

Duke University1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2011年11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
25
试验地点
1
主要终点
To evaluate the accuracy, robustness, and efficacy of MRI for tumor motion measurement.

研究概览

简要总结

This study is a research initiative established to explore the use of magnetic resonance imaging (MRI) as a tool for detecting organ motion as it pertains to planning radiation therapy.

详细描述

The goal with radiation therapy is to treat the defined tumor and spare the surrounding normal tissue from receiving dose above specified tolerance doses. There is evidence of improved local control and survival with higher doses of radiation, however, at the same time there is the need to spare normal tissues from higher doses of radiation. Technologies that allow the delivery of an increased radiation dose to the tumor while sparing normal tissue have the potential of improving the therapeutic ratio. However, the development of these technologies has been hampered by organ respiratory motion particularly in the case of the lungs and liver. Inadequate radiation coverage of a tumor secondary to organ motion can lead to delivering a lower dose to a portion of the tumor. Making the field of radiation larger to account for organ motion results in unnecessary radiation dose to surrounding healthy tissues. It is therefore desirable to document the extent of motion of the organ in question prior to carrying out the radiation treatment planning. The organ motion impacts directly on the radiation dose distribution in the treatment volume.

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 or metastatic tumors in the lungs, liver, or pancreas
  • Patients undergoing a planning CT scan in the Department of Radiation Oncology with tumor motion assessment - planning 4D-CT ordered by the treating Radiation Oncologist
  • Signed, specific informed consent prior to study entry

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, etc
  • Pregnant or breast-feeding women
  • Subjects who have difficulty lying flat on their back for extended periods of time

结局指标

主要结局

To evaluate the accuracy, robustness, and efficacy of MRI for tumor motion measurement.

时间窗: During MRI approx 1 hour

MRI and CT ( all subjects will have a standard of care CT scan) data in DICOM format will be collected for analysis using commercial or customized - developed software. Image quality will be assessed based on signal-to-noise (SNR), contrast-to-noise ratio (CNR), and the presence of image artifacts. Data to be computed include, but are not limited to, tumor volumes (gross tumor volume, internal target volume, planning target volume, etc.), tumor motion parameters (range, trajectory, frequency, variation, probability distribution, etc.), and treatment plan parameters (target coverage, dose-volume-histogram, etc.).

Tumor contrast-to-noise ratio (CNR)

时间窗: During MRI approx 1 hour

Difference between CNR is measured by 4D-MRI and 4D-CT

Tumor Motion

时间窗: During MRI approx 1 hour

Difference between tumor motion as measured by 2D cine-MRI vs 4D-MRI vs 4D-CT

Tumor volume

时间窗: During MRI approx 1 hour

Free breathing/breath-hold MRI will be compared to free breathing/breath-hold CT

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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