Judging MR Simulation Procedures: A Phase I-II Study of the Use of Magnetic Resonance Imaging Simulation in the Planning of Radiation Treatments
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Feasibility of acquiring MRI simulation prior to radiation therapy planning
研究概览
简要总结
This is a master protocol for a prospective Phase I-II study evaluating feasibility and efficacy of incorporating magnetic resonance imaging (MRI) simulation into the planning of radiation treatments.
详细描述
This is a Phase I/II clinical trial. A Phase I clinical trial tests the feasibility and safety of an investigational intervention. "Investigational" means that the process targeting high doses of radiation to the tumor based on MRI is still being studied. This research study is a Feasibility Study, which means it is the first-time investigators at this institution are examining this type of MR-guided dose planning. The U.S. Food and Drug Administration (FDA) has cleared MRI planning for use.
- In Phase I of this study, will prospectively determine the feasibility of using an MRI simulator to plan radiation therapy.
- In Phase II, the efficacy of adjusting RT based on MRI simulation will be explored, either by utilizing an MRI-simulation and synthetic CT to plan treatment or by dose-painting based on functional MRI data
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Participants must have a confirmed malignancy requiring radiation therapy.
- •Age: 18 years or older
- •ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
- •Ability to understand and the willingness to sign a written informed consent document.
- •Disease-specific eligibility criteria will be specified in the appropriate subprotocol.
排除标准
- •For MRI involving contrast, history of allergic reactions attributed to gadolinium based IV contrast. Note: If patient will not receive contrast, this is not applicable
- •Participants who cannot undergo an MRI
- •Disease-specific exclusion criteria will be specified in the appropriate subprotocol
研究组 & 干预措施
Phase II MR Simulation Protocol: Track A
MR-only Radiation Therapy Simulation MRI-simulation and synthetic CT to plan treatment
干预措施: MRI Simulator (Device)
Phase II MR Simulation Protocol: Track B
Adjusted Margin or / Dose Painted RT Based on Imaging of MR Simulator (e.g. biological imaging or higher resolution imaging)
干预措施: MRI Simulator (Device)
Phase II MR Simulation Protocol: Track B
Adjusted Margin or / Dose Painted RT Based on Imaging of MR Simulator (e.g. biological imaging or higher resolution imaging)
干预措施: Radiation Therapy (Radiation)
Phase I MRI Simulation
This research study involves a screening period to determine eligibility.
- Radiation mapping to define the target for radiation.acquiring MR data at the specified timepoint in a patient's care plan and ability to identify the radiation target and develop a radiation therapy plan on the MR data.
干预措施: MRI Simulator (Device)
Phase I MRI Simulation
This research study involves a screening period to determine eligibility.
- Radiation mapping to define the target for radiation.acquiring MR data at the specified timepoint in a patient's care plan and ability to identify the radiation target and develop a radiation therapy plan on the MR data.
干预措施: Radiation Therapy (Radiation)
Phase II MR Simulation Protocol: Track A
MR-only Radiation Therapy Simulation MRI-simulation and synthetic CT to plan treatment
干预措施: Radiation Therapy (Radiation)
结局指标
主要结局
Feasibility of acquiring MRI simulation prior to radiation therapy planning
时间窗: 1 Year
Feasibility is defined as successfully enrolling patients, successfully acquiring MR data at the specified timepoint in a patient's care plan and ability to identify the radiation target and develop a radiation therapy plan on the MR data
Proportion of patients with QOL decline exceeding 2 x MID
时间窗: baseline up to 24 months
12 points; MID of the EPIC-26 urinary irritative/obstructive domain is 6 points) measured by EPIC-26 urinary irritation/obstruction domain from baseline to 2 years
次要结局
- Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0(24 Months)
- PSA progression (nadir + 2) at 2 years from treatment initiation(24 months)
- MRI evidence of disease at 2 years from treatment initiation.(24 Months)
- Progression free survival(24 months)
- Change in coverage of target volumes between CT simulation and MRI simulation(24 Months)
- Change in dose to organs at risk (OARs) between CT simulation and MRI simulation(24 Months)
- Change in target volumes between CT simulation and MRI simulation(24 Months)
- Performance of the synthetic CT in RT planning(24 Months)
研究者
Raymond Mak
Principal Investigator
Brigham and Women's Hospital