A Single Institution Pilot Study Using a Head and Neck Maskless Immobilization Device (MID) for Patients With Head and Neck Cancer or Intracranial Tumors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Accuracy Measured by Quantifying the Difference in Translational Shifts From the Daily Setup to Planning CT Scan Digitally Reconstructed Radiograph
研究概览
简要总结
This pilot clinical trial studies how well head and neck maskless immobilization device works in immobilizing patients with head and neck cancers or intracranial tumors undergoing radiation therapy. Maskless immobilization device may help to prevent movement of head during radiation therapy and immobilize patients with the same accuracy and reliability as the standard thermoplastic mask routinely used for patients receiving radiation therapy.
详细描述
PRIMARY OBJECTIVES:
I. To assess the setup accuracy and reproducibility of the maskless immobilization device (MID) in patients being treated for head and neck cancers or intracranial tumors who require radiation therapy
SECONDARY OBJECTIVES:
I. To assess the patient comfort and quality of life with the MID compared to the thermoplastic mask.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- 否
入选标准
- •Patients being treated for head and neck cancers who require radiation therapy or intracranial tumors, over a 2 to 7 week period of time
- •Age ≥ 18 years old
- •Subjects are capable of giving informed consent or have an acceptable surrogate capable of giving consent on the subject's behalf
- •Provide signed and dated informed consent form
- •Exclusion Criteria
- •History of prior trauma or orthopedic surgery to the cervical vertebral column/spine, which may interfere with the RT planning process
- •Patient requires a neck brace for medical reasons
- •Skull or bony defect in the area contacting the immobilization straps
- •RT delivered by clinical setup only (no CT simulation)
排除标准
- 未提供
结局指标
主要结局
Accuracy Measured by Quantifying the Difference in Translational Shifts From the Daily Setup to Planning CT Scan Digitally Reconstructed Radiograph
时间窗: Baseline to Day 15, an average of 31 days
The primary endpoints are to assess the setup accuracy and reproducibility with the Maskless Immobilization Device. Accuracy will be measured by quantifying the difference in translational shifts from the daily setup to planning CT scan digitally reconstructed radiograph (DRR). The magnitude of shifts will be compared to the shifts required using the gold standard thermoplastic mask. Translational shifts is defined as measuring the shifts in cm between the daily setup and the planning setup.
次要结局
未报告次要终点