A Feasibility Study of Magnetic Resonance Imaging (MRI) as a Platform for Image Guidance and Adaptive Radiation Therapy in Patients With Liver or Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Patient Satisfaction Survey
研究概览
简要总结
This is a single centre, single arm, prospective feasibility study that aims to see whether magnetic resonance imaging (MRI) as a source of image guidance before each radiation treatment fraction is feasible, and also if it may provide information that could potentially be used during the treatment to improve the radiation treatment plan.
Patients will have 5 MRIs with each of their RT sessions. If patients' RT treatment will consist of more than 5 fractions, only 5 MRIs will be done with any 5 RT fractions. Patients will be completing a short questionnaire at the end of each MRI. A patient questionnaire will also be completed at the end of the study to assess for patient satisfaction.
There will be 30 evaluable patients enrolled to the study.
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
- •Patients 18 years or older
- •Diagnosed with locally advanced pancreatic cancer or hepatocellular carcinoma being considered for treatment with chemoradiation, long course RT, or SBRT with curative intent or palliative intent, planned for 5 or more RT fractions
排除标准
- •- Contraindications for MRI: ferromagnetic prosthesis, pacemaker / implanted defibrillator, claustrophobia
研究组 & 干预措施
Pancreatic Cancer
Approximately 10 patients with pancreatic cancer will be enrolled to the study with the primary aim of determining the feasibility of using off-line MRI-guidance during the course of radiation treatment
干预措施: MRI (Other)
Liver Metastases
Approximately 10 patients with liver mets will be enrolled to the study with the primary aim of determining the feasibility of using off-line MRI-guidance during the course of radiation treatment
干预措施: MRI (Other)
Hepatocellular carcinoma
Approximately 10 patients with HCC will be enrolled to the study with the primary aim of determining the feasibility of using off-line MRI-guidance during the course of radiation treatment
干预措施: MRI (Other)
结局指标
主要结局
Patient Satisfaction Survey
时间窗: At study completion (day5 or week 5, depending on type of treatment)
To evaluate patient satisfaction with the MR guidance process, a modified version of a questionnaire previously used at our institution will be performed at the end of the study
MRI-Anxiety Questionnaire
时间窗: Prior to or before MR session 5 (day 5 or week 5, depending on type of treatment)
his instrument will be used to evaluate patient related anxiety after each MR
MRI-Anxiety Questionnaire
时间窗: Prior to or before MR session 1 (day 1 or week 1, depending on type of treatment)
This instrument will be used to evaluate patient related anxiety after each MR
MRI-Anxiety Questionnaire
时间窗: Prior to or before MR session 2 (day 2 or week 2, depending on type of treatment)
This instrument will be used to evaluate patient related anxiety after each MR
MRI-Anxiety Questionnaire
时间窗: Prior to or before MR session 3 (day 3 or week 3, depending on type of treatment)
This instrument will be used to evaluate patient related anxiety after each MR
MRI-Anxiety Questionnaire
时间窗: Prior to or before MR session 4 (day 4 or week 4, depending on type of treatment)
This instrument will be used to evaluate patient related anxiety after each MR
次要结局
未报告次要终点