Development and Evaluation of Imaging Acquisition and Analysis Methods for Optimization of MRI and/or CT in Radiation Oncology Simulation, Treatment Planning, and Response Assessment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 937
- 试验地点
- 11
- 主要终点
- evaluate the feasibility of new MRI or CT applications
研究概览
简要总结
Magnetic resonance imaging (MRI) is currently one of the standard diagnostic imaging methods used to diagnose tumor stage before treatment in the Radiation Oncology Department. It is also used to check responses to radiation after treatment. However, MRI isn't traditionally used in planning for radiation treatment or in checking treated tumor and tissue changes during radiation treatment. The goal is to find out the possible benefits of MRI imaging techniques in these settings of radiation treatment. The research aims are to study the possibility of using devices with new abilities such as the MR-Linac. The MR-Linac combines a radiation treatment machine with a diagnostic MRI scanner. This device will improve the quality of MRI-guided radiation treatment. The MR-Linac has functions that are currently not available in other combined imaging and radiation delivery devices. The MR-Linac does not provide additional imaging capabilities that are not currently available in other imaging devices.
Participating in this study would NOT change the current treatment plans, this will allow the investigators to use the MRI methods in research and future patient care.
详细描述
The purpose of this protocol is to demonstrate proof of concept and feasibility of new MRI or CT hardware, pulse sequences and data analysis software to plan and adapt radiotherapy treatment and to assess tumor response to radiotherapy (only FDA approved hardware are allowed in this study). Efforts to develop, modify and evaluate new or existing MR or CT imaging techniques must be a continuous practice with the goal of enhancing the use of MRI or CT during radiation therapy. The investigators therefore anticipate an ongoing need for such a protocol and believe the ability to perform such studies is critical to the translation of new imaging technologies from concept to routine clinical use. Under this protocol, modifications to the following items may be tested: pulse sequence programs, radiofrequency coils, reconstruction and processing software, other MR or CT system hardware and analysis software. A brief description of each of these items is described below. The potential risks associated with modifying each of these items, and the measures that will be taken to minimize these risks are described in subsequent sections.
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
- 是
入选标准
- •Men and women age 18 or older
排除标准
- •Anyone who would be normally excluded from undergoing an MRI examination as per Memorial Hospital for Cancer and Allied Diseases Screening Questionnaire
- •Participants/volunteers with a pacemaker, aneurysm clip or any other condition that would warrant avoidance of a strong magnetic field
- •Female participants/volunteers who are pregnant or nursing
- •Participants/Volunteers who are unable to comply or complete the MRI exam due to claustrophobia or high levels of anxiety
- •Participants/Volunteers from the vulnerable population, as defined by 45 CFR
- •Participants at higher risk due to age, frailty, or the emergent nature of their condition.
研究组 & 干预措施
participants undergoing radiation therapy & normal volunteers
Protocol participation will consist of one or more research MRI or CT exams not to exceed 45 minutes.
干预措施: MRI or CT (Device)
结局指标
主要结局
evaluate the feasibility of new MRI or CT applications
时间窗: 5 years
MRI or CT acquisition and analysis methods for radiotherapy planning or tumor response assessment during radiotherapy.
次要结局
未报告次要终点