PET Functional Imaging to Evaluate Cardiac Radiation Damage (EUCLID)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in mean standardized uptake value (SUV) changes in the heart
研究概览
简要总结
This clinical trial examines positron emission tomography (PET)/computed tomography (CT) in evaluating cardiac radiation damage in patients with lung or esophageal cancer. As part of the treatment for lung or esophageal cancer, patients will undergo radiation therapy. Sometimes, during this treatment, the heart is also subjected to some radiation which could affect its function, either increasing or decreasing the function. It is not known the consequences of this change nor is it known if doctors can detect the changes associated with the radiation. Sarcoidosis FDG positron emission tomography (PET)-computed tomography (CT) scans are a common way to image cardiac inflammation and myocardial viability. This study may help doctors image the heart before, during and after radiotherapy to monitor any changes.
详细描述
PRIMARY OBJECTIVE:
I. To characterize radiation-related functional imaging changes in the heart using sarcoidosis fludeoxyglucose F-18 (FDG) PET-CT imaging.
SECONDARY OBJECTIVES:
I. 1. To evaluate the ability of imaging changes in the heart to predict for overall survival (OS).
II. To evaluate the ability of imaging changes in the heart to predict for cardiac toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Provide signed and dated informed consent form
- •Willing to comply with all study procedures and be available for the duration of the study
- •Male or female, aged >= 18
- •Life expectancy >= 3 months as assessed by Radiation Oncologist
- •Mean heart dose estimated by Radiation Oncologist to be >= 5 Gy (physics dose or biologically equivalent dose)
- •Pathologically proven (either histologic or cytologic) proven lung cancer or esophageal cancer
- •Planned radiation treatment course for management of lung or esophageal cancer * Both standard and hypofractionation schedules are permitted
排除标准
- •Contraindication for FDG PET-CT scans as assessed by the radiation oncologist or nuclear medicine radiologist
- •Palliative radiation doses defined as 20 Gy in 5 fractions
研究组 & 干预措施
Diagnostic (sarcoidosis FDG PET-CT)
Patients undergo sarcoidosis FDG PET-CT of the heart before, during and, after radiotherapy.
干预措施: Fludeoxyglucose F-18 (Other)
Diagnostic (sarcoidosis FDG PET-CT)
Patients undergo sarcoidosis FDG PET-CT of the heart before, during and, after radiotherapy.
干预措施: Positron Emission Tomography (Procedure)
Diagnostic (sarcoidosis FDG PET-CT)
Patients undergo sarcoidosis FDG PET-CT of the heart before, during and, after radiotherapy.
干预措施: Computed Tomography (Procedure)
Diagnostic (sarcoidosis FDG PET-CT)
Patients undergo sarcoidosis FDG PET-CT of the heart before, during and, after radiotherapy.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Change in mean standardized uptake value (SUV) changes in the heart
时间窗: Up to 30 months after radiotherapy
Measured by sarcoidosis fludeoxyglucose F-18 (FDG) positron emission tomography (PET)-computed tomography (CT) scans.
次要结局
- Cardiac toxicity judged to be secondary to radiotherapy by cardiologist and radiation oncologist(Up to 30 months after radiotherapy)
- Overall survival(Up to 30 months after radiotherapy)
- Ability of pre- to post-radiotherapy SUV changes in the heart(Up to 30 months after radiotherapy)
- Cardiac toxicity(Up to 30 months after radiotherapy)
- Cardiac related death(Up to 30 months after radiotherapy)