Multiparametric MRI for Assessing Radiotherapy Treatment Response of Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- MRI use to predict treatment response
研究概览
简要总结
Prostate cancer is one of most common cancers in America, affecting 1 in 6 men. External beam radiation therapy is one of the common methods to treat prostate cancer. Although radiotherapy is effective, side effects to the adjacent normal organs limit the therapeutic ratio. Those side effects are usually associated with the radiation damage of the normal tissue surrounding prostate, e.g. bladder, urethra and rectum etc. Both effectiveness and the side effects of radiation treatment are often accessed after whole course of radiotherapy, which makes the early intervention difficult. The current research project is a feasibility study of utilizing advanced magnetic resonance imaging (MRI) techniques to access radiotherapy treatment response of prostate cancer during and right after radiotherapy.
Many advanced MRI techniques, e.g. spectroscopy (MRS), diffusion-weighted (DWI), dynamic contrast enhanced (DCE) perfusion weighted images, have been used in radiology departments for diagnostic purpose. This research project is to study the feasibility of using advanced MRI sequences to monitor tissue response during and after radiotherapy. The tissue changes revealed from MRI can provide physicians early information on possible tumor recurrence and normal tissue toxicity, therefore, the early intervention may be possible to spare normal tissue and cure the patient. The project is designed to combine several different advanced MRI imaging techniques systematically to study tissue changes during radiotherapy, which has not been seen elsewhere to date.
Another important goal of this research project is to study the feasibility of associating functional MRI with radiation treatment dose distribution. Tissue response during radiation treatment depends on dose. The functional MRI can provide more information than simple anatomic information. Mapping the functional MRI spatially and associating them with 3D dose distribution in radiation treatment planning system is one important step to quantitative assess the relationship between radiation treatment and tissue changes due to the radiation.
详细描述
Twenty patients who are diagnosed with prostate cancer and will undergo external beam radiotherapy will be recruited in this study. Three MR scans of each patient under the study will be performed at different time points. Each MR scan will include several advanced MR imaging sequences (including but not limited to MR spectroscopy, diffusion and perfusion imaging, which are used in routine clinical radiology settings) in addition to typical T1 and T2 weighted MR imaging. The MR scans will be conducted at Radiation Oncology department with the position similar to the treatment position.
The first MR scan will happen prior to the radiation treatment during the scheduled patient simulation for baseline information. The T1- and T2-weighted MRI will be used for delineation of prostate gland as a part of routine treatment planning process. Additional functional MR (DWI/ADC. DCE, etc) images will be used as baseline of this study. The second MR scan with the same sequences will happen in the mid course of radiation treatment. And the third MR scan with the same sequences will happen at end of radiation treatment. Because the participated patients will come to radiation oncology department daily for their routine radiation treatment there will be no additional visits required for patients. The first scan will happen during the same day when patients undergo CT and MRI simulation for treatment planning as part of their standard cares. Two extra MRI scans will be performed as part of this research protocol. The second and third scans will happen on one of treatment days.
While it is anticipated that the advanced MRI techniques will eventually play an important role in the early intervention of radiation treatment and patient management of radiotherapy of prostate cancer at JHH, no modification of the radiation treatment and patient management will be based on the imaging information acquired during this feasibility study. All participated patients will undergo the routine radiation treatment as all other prostate cancer patients managed in our department.
The imaging data acquired will be systematically processed and analyzed along with correlating to radiation treatment dose distribution. All MRI data from three different scans need to be registered to each other and then register to planning CT. The anatomical, functional changes of tumor and normal tissues during radiation treatment will be accessed and correlated to radiation dose. After radiotherapy, all enrolled patients will be followed up the same way as normal post treatment management. The short term or long term tumor response and normal tissue side effects will also be collected under routine clinical follow up.
Following MRI based biomarker will be assessed:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically-confirmed prostate cancer
- •Plan to undergo external radiation treatment of prostate cancer
排除标准
- •Patients who cannot undergo an MRIs
- •Patients who are allergic to gadolinium based contrast agent
- •Patients who have cardiac pacemaker or other electronic or metal implant
- •Patients who have chronic kidney disease
结局指标
主要结局
MRI use to predict treatment response
时间窗: 2 months
To study the feasibility of using magnetic resonance imaging (MRI) to predict treatment response in patients with prostate cancer undergoing radiation therapy. The anatomical, functional, and location changes in tumor or normal tissues during the radiation will be assessed and correlated with MRI data and treatment dose. Hypothesis one: Functional or anatomical MRI signal changes during the radiotherapy can be used as predictors to assess treatment response. We anticipate observing dose dependent MRI signal changes during the radiation treatment.
次要结局
- Evaluating MRI use to predict functional radiation treatment dose distribution(2 months)