NCT02769299已完成不适用
Cardiotoxicity of Radiation Therapy (CTRT)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 147
- 试验地点
- 1
- 主要终点
- Number of CV injury
研究概览
简要总结
The overall objective of this proposal is to determine the utility of sensitive imaging and biomarker measures in detecting subclinical cardiotoxicity across a spectrum of radiation doses to the heart. We will focus specifically on patients receiving photon or proton chest radiotherapy. Our broad working hypothesis is that RT induces early, subclinical CV injury, as evidenced by cardiomyocyte inflammation and necrosis, and worsening CV function.
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
- •Age 18 years or older.
- •Patients with left sided breast cancer newly initiating fractionated whole breast/chest wall with regional nodal photon or proton radiation therapy.
- •Patients with right sided breast cancer with newly initiating fractionated photon or proton radiation therapy with mediastinal nodal proton or photon radiation therapy that will include cardiac dose.
- •Lung cancer patients treated with definitive intent (greater than or equal to 50 Gy) using fractionated thoracic radiotherapy with proton or photon radiation therapy. Patients receiving concurrent chemotherapy will be allowed.
- •Patients with mediastinal lymphoma, whose lowest extent of mediastinal disease is at or below the level of the carina, treated with consolidative radiation with definitive intent (greater than or equal to 20 Gy) using fractionated thoracic radiotherapy with proton or photon radiation therapy.
- •Ability to read and comprehend English.
排除标准
- •Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
- •Patients receiving stereotactic body radiotherapy
- •Patients unable to undergo MR imaging will be excluded from the optional MR, but will not be excluded from the main study.
- •Life expectancy less than 12 months
- •Vulnerable patients as noted in 5 below (children, pregnant women, fetuses, neonates, or prisoners)
- •Patients with estimated glomerular filtration rate of less than 60 ml/min/1.73sq.m will be excluded from the optional MR, but will not be excluded from the main study.
- •Non-diagnostic echocardiography windows
结局指标
主要结局
Number of CV injury
时间窗: 8 months
次要结局
未报告次要终点
研究者
研究点 (1)
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