Early Imaging Biomarkers to Predict Radiation-Induced Cardiopulmonary Toxicity in Patients With Thoracic Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Change from Baseline in Lung Function
研究概览
简要总结
The purpose of this study is to investigate if cardiac MRI, blood biomarkers, and lung CT scans can detect early changes to the associated with radiation therapy in patients receiving radiation treatment for thoracic cancer.
详细描述
This study seeks to investigate the utility of novel imaging biomarkers, namely whole lung volumetric CT scans and cardiac MRI, to non-invasively identify early pathologic changes in pulmonary and cardiac function resulting from thoracic radiation. The ability to identify these changes during the course of treatment offers a powerful tool to optimize radiation dose distributions within uninvolved normal tissue by adapting treatment to the individual patient response. In addition it may lead to other therapeutic interventions designed to reduce long term cardiopulmonary toxicity.
The cardiac MRI will be performed using Aminophylline, Gadopentetate Dimeglumine and Regadenoson. These are not FDA approved for this purpose, but are being used off label and are IND exempt. Additionally, patients will be consented with an optional choice to retain research blood samples for 15 years after the completion of the study. This will allow cutting edge analysis for biomarkers that may be discovered in the future.
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
- •Patients receiving once daily fractionated intrathoracic radiation therapy for:
- •Stage IIA-IIIB non-small cell lung cancer
- •Limited stage small cell lung cancer
- •Stage I-III esophageal cancer (neoadjuvant or definitive)
- •Patients must be 18 years of age or older
- •Must not be claustrophobic
- •Must have adequate kidney function
排除标准
- •Patients with small cell lung cancer receiving twice daily (b.i.d.) radiation
- •Patients with esophageal cancer receiving trastuzamab
- •Pregnancy or lactation
- •Claustrophobia
- •Inability to lie flat for 60-90 minutes
- •Renal dysfunction with eGFR <60 mL/min/1.73 m2
- •Allergy to gadolinium containing contrast media
- •Implanted devices, metallic hazards or other conditions presenting a contraindication to 3Tesla cardiac MRI
结局指标
主要结局
Change from Baseline in Lung Function
时间窗: 1 Year post treatment
To characterize longitudinal changes in lung function using a voxel-wise image analysis technique of whole-lung CT scans in patients undergoing intrathoracic radiation therapy.
次要结局
- Change from Baseline in Myocardial Tissue(1 Year post treatment)
- Radiation Predictors from Baseline in Cardiopulmonary Changes(1 Year post treatment)