Pilot Study of a Novel Patient Position Monitoring System for Beam Gated Radiation Therapy of Malignancies of the Chest and Upper Abdomen
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Feasibility of eMotus system as defined by frequency of successfully delivered treatment fraction
研究概览
简要总结
This study will evaluate the feasibility of using this novel patient position monitoring system for patients receiving radiation therapy to targets involving the chest or upper abdomen, as these are the most affected by respiratory motion. This motion monitoring system will be incorporated with standard of care on-board CT imaging to confirm that the respiratory position is tracking the tumor target appropriately.
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
- •Eligibility Criteria
- •Planning to receive a course of radiation therapy that, per the treating radiation oncologist, requires motion management at the time of CT simulation and during treatment. Types of treatments that require motion management during radiation therapy include treatments to the lung, heart, breast, and upper abdomen (pancreas, liver, adrenals). These may include either free-breathing treatments or breath-hold treatments.
- •At least 18 years of age.
- •No documented allergy to medical grade adhesives.
- •Able to understand and willing to sign an IRB approved written informed consent document.
排除标准
- 未提供
研究组 & 干预措施
Motion management system during standard of care treatment
Patients will wear the motion management system (eMotus) during their CT simulation scan and each of their radiation therapy treatments (no more than 15 fractions). CT simulation will take approximately 40 minutes and radiation treatments will take approximately 15-45 minutes depending on the patient's plan. Patients will complete questionnaires collecting feedback on the device after receiving their last fraction of treatment.
干预措施: Patient Position Monitoring System (Device)
结局指标
主要结局
Feasibility of eMotus system as defined by frequency of successfully delivered treatment fraction
时间窗: Enrollment to completion of radiation therapy (estimated total time is 1 month)
The feasibility of the eMotus fiber optic motion sensor system will be measured as the frequency of scheduled treatment fractions delivered successfully using eMotus. Success is defined as delivery of a treatment fraction in one on-table attempt without requiring the use of a secondary (backup) motion management system. Unsuccessful delivery of a treatment fraction will be defined as more than one attempt for gating without reproducible positioning, breath-hold, or surface guidance feedback such that the treatment could not be delivered with eMotus. Descriptive statistics will be collected and reported to determine the proportion of successful motion monitoring events.
次要结局
未报告次要终点