Identification of Early Cardiac Injury From Radiation Therapy Using Cardiac Magnetic Resonance Imaging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Change in myocardial strain
研究概览
简要总结
The investigators will identify 10 patients in the department of radiation oncology who will receive standard of-care radiation therapy, and the treating radiation oncologist anticipates a mean left ventricular dose of at least 5 Gy. Patients will be evaluated by CMRI before and within one week of the completion of RT. We will compare the pre- and post-RT CMRI scans to identify changes related to radiation exposure. Our primary endpoint will be changes in myocardial strain. Secondary endpoints will include other CMRI parameters.
详细描述
Cardiac toxicity is a significant cause of morbidity and mortality in cancer survivors after radiation therapy (RT) to the chest. Typically, cardiotoxicity is identified years after radiation exposure. Emerging clinical data show that subclinical injury can be identified immediately after treatment. Early identification of subclinical injury may enable intervention to reduce the risk of progression to clinically significant toxicity. The investigators hypothesize that cardiac magnetic resonance imaging (CMRI) will detect early cardiac injury after RT and that imaging changes will be associated regionally with cardiac radiation dose.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision to sign and date the consent form.
- •Stated willingness to comply with all study procedures and be available for the duration of the study.
- •18 - 100 years of age
- •KPS ≥ 70 or ECOG ≥ 1
- •Will receive RT using computed tomography (CT)-based treatment planning that will involve delivery of dose to the heart
- •Estimated by the treating radiation oncologist at the time of simulation to have a mean left ventricular dose of at least 5 Gy
排除标准
- •Previous history of RT to the thorax or breast
- •Implanted device that is non-MRI compatible or any implanted device in chest
- •Known gadolinium contrast allergy or other contraindication to CMRI scan. Patients needing sedation or medication for claustrophobia or anxiety will not be excluded from participating.
- •Found to be pregnant or breast-feeding
- •Known history of atrial fibrillation or frequent ventricular or atrial premature beats
- •Known history of chronic kidney disease (such as, but not limited, to a glomerular filtration rate < 60mL/min)
- •History of coronary artery disease or myocardial disease
- •History of hypertension, requiring >1 antihypertensive agent to maintain blood pressure <140/90
- •Known history of valvular stenosis or regurgitation of > moderate severity
- •Known history of heart failure (defined as baseline New York Heart Association Class III or IV (see Appendix A)
- •Systolic blood pressure < 90mmGy
- •Pulse < 50/minute
- •Known history of pulmonary hypertension or elevated right ventricular systolic pressures.
- •Suspicion or diagnosis of amyloidosis
- •Suspicion or diagnosis of hemochromatosis
结局指标
主要结局
Change in myocardial strain
时间窗: 2 years
Assess for a change in myocardial strain, as measured by CMRI scans performed before and after RT
次要结局
- T1 pre- and post-contrast values(2 years)
- Extracellular volume fraction(2 years)
- T2 values(2 years)
- End systolic volume(2 years)
- Left atrial volume(2 years)
- Late gadolinium enhancement(2 years)
- End diastolic volume(2 years)
- Left ventricular ejection fraction(2 years)
- Wall thickness(2 years)
- Left ventricular mass index(2 years)