Collection of Head Images During Radiotherapy (CHIRP)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Rotational head motion between different radiation therapy treatment sessions
研究概览
简要总结
The primary objective of this observational study is to quantify the translation, rotation, and deformation of patient head positions of head and neck cancer patients over the course of a radiation therapy treatment for head and neck cancer. This objective will be achieved by comparing X-ray images collected during each treatment session with those obtained from the planning CT scan. Secondary objectives include (1) the use of the collected X-ray images to develop realistic artificial X-ray images where patient movement can be simulated and (2) to determine whether motion can be detected from individual X-ray images acquired during radiation therapy treatment.
详细描述
Participants will undergo their radiation therapy treatment for HNC as planned and per the routine clinical management protocol. As part of this routine treatment, multiple x-ray images will be acquired to assist in accurate positioning of the patient for their planned radiation therapy. Normally these images are stored for a few days and then discarded. This study will be collating, storing and analysing these images. These X-ray images will be paired with the corresponding pre-treatment CT scan that is routinely acquired for each patient, as well as the locations of organs of interest, such as the tumour and surrounding structures. The patient treatment plan will also be collated, as it will allow for analysis of how any motion affects the accuracy of dose delivery. The patient radiation treatment delivery record will be collected to help sort and categorise the acquired images. Information on potential confounding or interacting factors will be collected: demographic information will be collected including sex, age, tumour stage and histology.
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
- •A diagnosis of head and neck cancer (any stage)
- •Age 18 years or greater
- •Receiving radiation therapy to the head and neck with a thermoplastic immobilisation mask
- •An ECOG score in the range of 0 to 2
- •Any other prior or concurrent therapy allowed
排除标准
- •People with cognitive impairment which would preclude them from providing informed consent
- •People who are unable to speak and read English and for whom obtaining consent would be difficult.
结局指标
主要结局
Rotational head motion between different radiation therapy treatment sessions
时间窗: 8 weeks
Rotation error (degree)
Head deformation between different radiation therapy treatment sessions
时间窗: 8 weeks
Deformation error (mm)
Translational head motion between different radiation therapy treatment sessions
时间窗: 8 weeks
Translation error (mm)
次要结局
- Difference in mean absolute error between artificial and real X-rays(8 weeks)
- Difference in structural similarity (SSIM) indexes between artificial and real X-rays(8 weeks)