Radiation Induced Cardiopulmonary Injury in Humans
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Changes in Regional Lung Function
研究概览
简要总结
The purpose of the study is to assess the time, dose dependence, and fraction-size dependence of radiation (RT)-induced changes in regional lung and heart perfusion/function/structure following thoracic RT delivered using newer IMRT/conformal/radiosurgery techniques. The PI hopes to develop models to better relate and predict RT-induced changes in regional lung and heart perfusion/function/structure with changes in global cardiopulmonary function. Patients will undergo pre- and serial post-RT lung and heart assessments to better understand RT-induced regional heart/lung changes.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Patients who are to receive 3D-planned RT for tumor within and around the thorax.
- •Patients receiving incidental RT to portions of the heart are eligible.
- •Estimated minimum expected life expectancy of one year
- •Able to undergo the required study-related tests for regional lung injury and regional heart injury
- •Patients of child bearing potential age must have a negative pregnancy test and must agree to use appropriate birth control measures while in the study.
- •Patients must be able to give informed consent. Informed consent will be obtained prior to enrollment.
排除标准
- •Patients who are anticipated to have thoracic surgery post-RT are ineligible.
- •Patients with large mediastinal/hilar tumors compressing the airways/vessels, and negatively impacting on cardiovascular function
- •Pregnant or nursing women.
结局指标
主要结局
Changes in Regional Lung Function
时间窗: Up to 4 years post CRT
Changes in Regional Heart Function
时间窗: Up to 4 years post CRT
Relating RT-Induced Changes in Regional injury to Global Cardiopulmonary Changes
时间窗: Up to 4 years post CRT
次要结局
未报告次要终点