Pre- and post-treatment evaluation of lung function with Xenon-gas enhanced Dual-Energy CT-imaging in patients undergoing radiotherapy
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- UZ Brussel
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The primary endpoint of this study is to quantify radiotherapy-induced functional and anatomical changes by comparing pre- and post-treatment ventilation maps. Radiotherapy-induced changes will be assessed both qualitatively, by visual analysis of differences in lung parenchyma structure and ventilation patterns (hypo- or hyperdense areas on colour coded Xe-concentration maps of the lungs), and quantitatively, by computing local differences in ventilation metrics between pre- and post-treatment.
研究概览
简要总结
The primary objective of this trial is to acquire high-resolution anatomical and functional information on lung ventilation using a gas mixture of 30 Vol% Xe in 70 Vol% O2 as contrast agent in combination with DECT-imaging in lung and breast cancer patients scheduled to undergo radiotherapy. Ventilation maps will be generated to evaluate the effect of radiotherapy on the lung parenchyma in lung and breast cancer patients.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Lung and breast cancer having a TNM classification I-IIIa.
- •Between 50 and 80 years old.
- •No prior cancer treatment.
- •Breath hold for 3 seconds
- •Patients who are in stable condition or who are not hospitalized in an ICU.
- •Patients who are not suffering from COPD GOLD IV.
- •Patients who signed informed consent forms.
排除标准
- •No lung or breast cancer having a TNM classification I-IIIa.
- •Younger than 50 or older than 80 years old.
- •Received prior cancer treatment.
- •Cannot perform a 3 s breath hold
- •Patients who are in an unstable condition or who are hospitalized in ICU.
- •Patients who are suffering from COPD GOLD IV.
- •Patients who did not sign informed consent forms.
结局指标
主要结局
The primary endpoint of this study is to quantify radiotherapy-induced functional and anatomical changes by comparing pre- and post-treatment ventilation maps. Radiotherapy-induced changes will be assessed both qualitatively, by visual analysis of differences in lung parenchyma structure and ventilation patterns (hypo- or hyperdense areas on colour coded Xe-concentration maps of the lungs), and quantitatively, by computing local differences in ventilation metrics between pre- and post-treatment.
The primary endpoint of this study is to quantify radiotherapy-induced functional and anatomical changes by comparing pre- and post-treatment ventilation maps. Radiotherapy-induced changes will be assessed both qualitatively, by visual analysis of differences in lung parenchyma structure and ventilation patterns (hypo- or hyperdense areas on colour coded Xe-concentration maps of the lungs), and quantitatively, by computing local differences in ventilation metrics between pre- and post-treatment.
次要结局
- The secondary endpoint of this trial is to perform an extensive evaluation on the effect of RT on the lung parenchyma of lung- and breast cancer patients using ventilation metrics derived using a gas mixture of 30Vol% Xe in 70Vol% O2 as contrast agent combined with DECT.
研究者
Nico Buls
Scientific
UZ Brussel