Prospective Pilot Study of Early Markers of Radiation-Induced Cardiac Injury in Patients With Left-Sided Breast Cancer Receiving Photon or Proton Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Proportion of participants with changes in cardiac function.
研究概览
简要总结
This is a pilot study to determine if there are changes in heart function following completion of radiation therapy for breast cancer as measured by cardiac magnetic resonance imaging (cardiac MRI) scans. Additional purposes of this study are to assess cardiac side effects from radiation treatment, evaluate cardiac MRI changes by radiation technique, and compare quality of life questionnaires.
详细描述
As part of this study, participants will have a cardiac MRI at baseline and a follow-up cardiac MRI within 1 year after completion of standard radiation therapy for left-sided breast cancer. The cardiac MRI scans will be evaluated to determine if there are changes in cardiac function within 1 year after radiation treatment.
Patients will be asked to complete a questionnaire before and after treatment that asks about their health and any symptoms they may be having.
Physical exams and any other standard of care service or treatment will be at the discretion of the treating physician.
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
- •Left-sided breast cancer stage I-III.
- •Indications for adjuvant regional nodal and breast or chest wall radiation therapy (RT).
- •Women and men are allowed.
- •Must be at least 18 years old at time of consent.
排除标准
- •Pregnant and/or breastfeeding women or patients of child-producing potential not willing to use contraception while on study.
- •Prior history of cardiovascular disease per physician discretion.
- •Stage 0 and IV breast cancer.
- •Prior radiation therapy to chest.
- •Concurrent trastuzumab per physician discretion.
结局指标
主要结局
Proportion of participants with changes in cardiac function.
时间窗: 1 year after completion of radiation therapy
A change in cardiac function may include shifts from baseline measures of LV mass, strain, ejection fraction, and late gadolinium enhancement.
次要结局
- Proportion of patients with serious cardiac side effects.(1 year after completion of radiation therapy)
- Mean quality of life score.(1 year after radiation treatment)