使用 Northern Alberta Linac-MR (Northern LIGHTs - 1) 的 MR 成像研究
北艾伯塔 Linac-MR 图像引导人体临床试验 - 1
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.
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Nawaid Usmani, MD
- 电话号码：780-432-8518
- 邮箱：Nawaid.Usmani@ahs.ca
学习地点
-
-
Alberta
-
Edmonton、Alberta、加拿大、T6G 1Z2
- 招聘中
- Cross Cancer Institute
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Adults ≥ 18 years of age
- Patients deemed fit to undergo high dose external beam radiation therapy by their attending radiation oncologist
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：设备可行性
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：MR Imaging on the Alberta linac-MR P3 system
All participants will undergo a single MR imaging session (30-40 minutes) on the Alberta linac-MR P3 system. |
Single MR imaging session to develop and optimize the necessary MR sequences on the Alberta linac-MR P3 system to allow for MR-guided radiotherapy. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
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)
大体时间：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. |
Through study completion, approximately 7 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Quantify the patient experience on the Linac-MR
大体时间：After the first and last scan, up to 5 weeks
|
Participants will complete a questionnaire at the end of their first scan regarding their experience having imaging done on the Linac-MR. Participants taking part in the optional sub-study will complete the same questionnaire at the end of their last set of imaging. |
After the first and last scan, up to 5 weeks
|
合作者和调查者
调查人员
- 首席研究员：Nawaid Usmani, MD、Cross Cancer Institute, Alberta Health Services
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- IIT-0013
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
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研究美国 FDA 监管的设备产品
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