Northern Alberta Linac-MR Image-Guided Human Clinical Trials - 1
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Number of high-quality MR image data sets acquired for each major tumour site (prostate, liver, lung, CNS, breast, gynecological, pancreas, and head and neck)
研究概览
简要总结
Cancers are often treated with external beam radiotherapy. Current radiotherapy treatments are performed using computed tomography (also known as CT) scans which may not always clearly identify the cancer. In some instances, magnetic resonance imaging (MRI) may be able to better identify cancers. Therefore, efforts are currently underway to use the MRI scans to improve radiotherapy treatments or eventually even use radiotherapy equipment that only uses MRI scans to guide treatments. This new technology that will only use MRI scans to guide treatments is called the Linac-MR (linear accelerator with an MRI). The purpose of this pilot phase of the study is to test whether the Alberta linac-MR P3 system at the Cross Cancer Institute can acquire high quality MR images safely. It will allow the researchers to develop the best collection of MR images possible with this new machine, in order to allow them to visualize tumors for future patients that are treated on this machine.
详细描述
This prospective, pilot phase, clinical trial is an imaging study to optimize the necessary MR sequences on the Alberta linac-MR P3 system to allow for MR-guided radiotherapy in adult patients with cancer that are treated with high dose external beam radiotherapy. Each participant will undergo a single MR imaging session (30 - 40 minutes) on the Alberta linac-MR P3 system. Towards the end of the study, patients will be approached to participate in an optional sub-study, where they will undergo a total of five MR imaging sessions (performed every two to five days) to allow for an assessment of inter-fraction motion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •Adults ≥ 18 years of age
- •Patients deemed fit to undergo high dose external beam radiation therapy by their attending radiation oncologist
排除标准
- •Patients with contraindications for MRI
- •Patients who are unable to lie flat and still for the duration of the expected scan acquisition
- •Patients who are unable to provide informed consent
结局指标
主要结局
Number of high-quality MR image data sets acquired for each major tumour site (prostate, liver, lung, CNS, breast, gynecological, pancreas, and head and neck)
时间窗: Through study completion, approximately 7 years
Clinical radiologists, medical physicists, and radiation oncologists will work together to develop MR sequences that can delineate tumour target volumes on the Alberta linac-MR P3 system. Over the course of the trial, the clinical radiologists will work with medical physicists to optimize these sequences to allow for the development of optimal MR images, with the goal to develop of series of protocols that can be utilized to provide clear MR image guidance for each tumour group.
次要结局
- Quantify the patient experience on the Linac-MR(After the first and last scan, up to 5 weeks)