跳至主要内容
临床试验/NCT01851161
NCT01851161终止不适用

Pulmonary Tumor Motion Reduction and Improved Breathing Reproducibility by Prone Patient Positioning in Radiation Therapy

Virginia Commonwealth University1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2010年5月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
23
试验地点
1
主要终点
Motion of the tumor and normal tissue evaluated in reference to the bony anatomy (vertebra)

研究概览

简要总结

This clinical trial studies prone patient positioning in reducing tumor motion and improving breathing reproduction in patients with lung cancer undergoing radiation therapy. Prone patient positioning during radiation therapy may help kill tumor cells without harming normal tissue.

详细描述

PRIMARY OBJECTIVES:

I. Quantify the three-dimensional tumor and normal tissue (thoracic and abdominal) motion, deformation and volume changes with the respiratory cycle during imaging in prone vs. supine positioning.

II. Quantify the three-dimensional tumor and normal tissue (thoracic and abdominal) motion, deformation and volume changes with the respiratory cycle and alterations thereof during a radiotherapy series.

OUTLINE:

Patients undergo one conventional computed tomography (CT) scan and one 4 dimensional CT (4D CT) scan in both supine and prone positioning before undergoing radiation therapy.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • Measurable disease on the planning computed tomography (CT) scan
  • Patients with lung cancer visible on fluoroscopic imaging or planning CT who are scheduled to receive external beam radiation treatment will be eligible for this study

排除标准

  • Patients requiring continuous supplemental oxygen due to the requirement of spirometry during all imaging studies
  • Pregnant females

结局指标

主要结局

Motion of the tumor and normal tissue evaluated in reference to the bony anatomy (vertebra)

时间窗: up to 90 days

The prone and supine image data acquired before the treatment onset will be used for planning. The computation of the doses will be performed on the dataset corresponding to the average position over the breathing pattern, based on previous studies indicating that a dose computation on this dataset approximates with sufficient accuracy the dose that will be received by the patient. The distributions of the tumor and normal tissue volumes in the prone and supine scans will be derived and the volume consistency will be assessed using the mean and the standard deviation of these distributions.

Consistency of the respiratory pattern, quantified by the cycle-to-cycle variation in the respiration trace during imaging in prone vs. supine positioning

时间窗: up to 90 days

During the 4D CT patient respiration trace will be recorded using the RPM optical tracking device. The average and standard deviation of the amplitude, period, end of inhalation position, and end of exhalation position of the respiration trace will be calculated. Paired t tests and F tests will be used to evaluate differences between these quantities for supine and prone positioning.

Consistency of the respiratory pattern, quantified by the cycle-to-cycle variation in the respiration trace during a radiotherapy series

时间窗: up to 90 days

During the 4D CT patient respiration trace will be recorded using the RPM optical tracking device. The average and standard deviation of the amplitude, period, end of inhalation position, and end of exhalation position of the respiration trace will be calculated. Paired t tests and F tests will be used to evaluate differences between these quantities for supine and prone positioning.

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)

Loading locations...

相似试验