Evaluation of Radiation Induced Pulmonary Hypertension Using MRI in Stage III NSCLC Patients Treated With Chemoradiotherapy. A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Changes in pulmonary artery pressure
研究概览
简要总结
In the radiotherapeutic treatment of lung cancer, the dose that can be safely applied to the tumour is limited by the risk of radiation induced lung damage. This damage is characterized by parenchymal damage and vascular damage. In rats, we have found that radiation-induced vascular damage results in increased pulmonary artery pressure. Interestingly, the consequent loss of pulmonary function could be fully explained by this increase in pulmonary artery pressure. We hypothesize that also in patients a radiation induced increase in pulmonary artery pressure can be observed after radiotherapy, which may contribute to the development of radiation pneumonitis.
The objective is to test the hypothesis that radiotherapy for lung cancer induces an increase in pulmonary artery pressure.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •WHO PS 0-2
- •Histological or cytological confirmation of non-small cell lung cancer or an 18F-FDG-positive, growing mass on CT-thorax suggestive of NSCLC.
- •Stage IIIA or IIIB
- •Patients with extensive mediastinal lymph node involvement (such as N3), or large primary tumour size
- •Adequate pulmonary function estimated by flow volume curves
- •Life expectancy of at least 6 months
- •Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol; those conditions should be discussed with the patient before registration in the trial.
- •Planned for 25 x 2.4 Gy, with concomitant chemotherapy
- •Before patient registration, written informed consent will be obtained.
排除标准
- •Presence of contra-indications for undergoing MRI
结局指标
主要结局
Changes in pulmonary artery pressure
时间窗: 6 and 12 weeks after completion chemoradiotherapy
次要结局
- Pulmonary artery velocity; right ventricle (RV) dimensions and RV-function(6 and 12 weeks after completion chemoradiotherapy)
- The incidence of radiological signs of pulmonary fibrosis according to CTCAE4.0(12 weeks after completion of treatment)
- The assessment of RV-dimensions and RV-function(6 and 12 weeks after completion chemoradiotherapy)
- The incidence of clinical signs of radiation pneumonitis according to SWOG-criteria(6 weeks after completion treatment)