Prospective Pilot Study of Assessment of Breath Hold as a Means to Mitigate the Risk of Radiation-associated Reductions in Regional Cardiac Perfusion in Patients With Left-sided Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Changes in cardiac perfusion
研究概览
简要总结
The purpose of this research study is to demonstrate that Deep Inspiration Breath Hold (DIBH), the technique used at the University of North Carolina (UNC) for left-side breast cancer radiation therapy, can reduce side effects to the heart.
详细描述
The primary objective of this study is to estimate the rate of radiation-associated regional myocardial perfusion defects in patients 6 months after breast/chestwall radiation with DIBH for left-sided breast cancer. Cardiac perfusion will be assessed using SPECT cardiac perfusion scans pre- and 6 months post-radiation.
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 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •signed an Institutional Review Board (IRB)-approved informed consent document for protocol
- •age >= 18 years
- •histologically confirmed left-sided breast cancer scheduled to undergo curative intent radiation treatment post lumpectomy or mastectomy
- •stage 0-III left-sided breast cancer (including DCIS)
- •SPECT score of 0 at baseline
- •radiation oncologist agrees target volume coverage will not be compromised via use of the DIBH technique along with conformal field shaping
排除标准
- •active cardiac disease, defined as a history of angina, arrhythmias, myocardial infarction, congestive heart failure, or any other cardiac condition, which in the opinion of the treating physician would make this protocol unreasonably hazardous for the patient
- •symptomatic pulmonary disease currently requiring regular medication including but not restricted to bronchodilators
- •concurrent chemotherapy
- •prior receipt of mediastinal radiation therapy
- •pregnant or lactating women
- •inability to understand and follow breathing instructions for the DIBH procedure
结局指标
主要结局
Changes in cardiac perfusion
时间窗: 6-months post radiation
Cardiac perfusion will be assessed using SPECT cardiac perfusion scans pre- and 6 months post-radiation. Any post-radiation summed-rest score (SRS) \> 0 will be counted as a perfusion defect in the calculation of the perfusion defect rate.
次要结局
- Wall-motion abnormalities(6-months post-treatment)