Impact of Continuous Positive Airway Pressure on Breathing Motion Amplitude
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change in Breathing Motion Characteristics at High CPAP Setting
研究概览
简要总结
This study involves a breathing motion assessment in healthy subjects before and after continuous positive airway pressure (CPAP) administration using MRI images.
The hypothesis for this study is that CPAP administration will significantly reduce breathing motion. This may help cancer patients who are undergoing proton radiotherapy, so they possibly will not have to hold their breath during the procedure.
详细描述
Minimally invasive techniques for tumor motion reduction that involve free-breathing patients have significant relevance in the context of radiation therapy, in particular proton radiotherapy. Tumor motion reduction has favorable implications for reduction of radiation doses to adjacent healthy organs, radiation plan robustness (accuracy/quality) and for treatment efficiency (reduction of treatment times). Using non-ionizing MRI with volunteers, the investigators will determine the extent to which continuous positive airway pressure (CPAP) reduces breathing motion (diaphragmatic excursion). The researchers will also investigate the parameter space associated with breathing motion reduction versus the amount of pressure applied, as well as timing of initiation of CPAP in relation to the imaging time point (to address whether an initial transient breathing state exists).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- 是
入选标准
- •Healthy adult female and males
- •Subject meets routine MRI safety criteria
排除标准
- •Known history of chronic obstructive pulmonary disease (COPD), asthma, or other chronic pulmonary illness
- •Any safety risk identified via MRI safety screening
结局指标
主要结局
Change in Breathing Motion Characteristics at High CPAP Setting
时间窗: Data acquisition for this portion of the study will require approximately 30 minutes.
Breathing motion at baseline and at initial (higher but tolerable) CPAP settings will be characterized using fast multi-slice, multi-phase 2D gradient-echo or spin-echo MRI sequences in the sagittal or coronal imaging planes over a large field of view covering the thoracic and upper-abdominal region. Specifically "4D-MRI" (or time-resolved MRI) will be generated from retrospective sorting of multi-slice 2D MRI. For these analyses, anatomic reference points (e.g., bright vessels) in multiple organ systems will be identified on the images, contoured or segmented; subsequently 3D motion patterns will be extracted for all anatomical references/features. Numerical simulations will be performed to determine hypothetical radiation target volume changes (cm\^3) at these anatomic locations assuming spherical tumors with a given set of tumor diameters (cm).
次要结局
- Change in Breathing Motion Characteristics at Lower CPAP Setting(Approximately 45 minutes into visit.)
研究者
Erik J. Tryggestad, Ph.D.
Associate Professor of Medical Physics
Mayo Clinic