MR-simulation in Radiotherapy for Prostate Cancer (FIMRA-P)
2022年3月17日 更新者：Guy's and St Thomas' NHS Foundation Trust
An Exploratory Study to Assess the Feasibility of Incorporating MR in the Radiotherapy Pathway of Patients With Prostate Cancer
To assess the feasibility of acquiring an MR scan in the radiotherapy treatment position as part of the patient's radiotherapy pathway and incorporating the data into our radiotherapy planning systems, so that it can be potentially used to reduce healthy tissue exposure to radiation.
Subsequently, the protocols and procedures established can be used to put the technique into routine clinical practice.
研究概览
详细说明
Conventional radiotherapy treatment planning uses computed tomography (CT) scans to provide an accurate 3-D picture of the local anatomy.
This helps the planners to maximise the radiation dose delivered to the prostate, whilst minimising the dose to surrounding normal tissue.
Magnetic resonance imaging (MRI) scanning is an established diagnostic imaging technique that provides even clearer images of the local anatomy.
However, until recently the technology hasn't existed to allow us to perform MRI scans with patients "set-up" in the position required to plan and deliver radiotherapy to the prostate.
This study is being performed to assess methods that may allow us to incorporate MRI scans into the radiotherapy planning process, which may further increase the accuracy of the treatment, reducing the irradiation of surrounding normal tissue and minimising toxicity.
研究类型
介入性
注册 (实际的)
40
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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London、英国、SE19RT
- Guy's and St. Thomas' NHS Foundation Trust
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
男性
描述
Inclusion Criteria:
- Written, voluntary, informed consent
- Age ≥ 18
- ECOG Performance Status ≤ 2
- Life expectancy > 12 months
- Histologically proven carcinoma of the prostate
- Radical radiotherapy +/- hormones indicated as the primary treatment modality
- Staging diagnostic MRI of the prostate need to be available for comparison.
- Adequate organ function and absence of other major concurrent illness, allowing
Exclusion Criteria:
- Inability to provide informed consent
- Impaired renal function (serum creatinine of > 200)
- Severely impaired liver function
- Patients with allergies or contra-indications to the gadolinium contrast agent that may be used in the study
- Severe claustrophobia or inability to tolerate MRI scans
- General contra-indications to MRI including cardiac pacemakers and defibrillators, metallic prosthetic devices, aneurysm clips and metal fragments in the eyes, as defined in MRI safety departmental protocols
- Serious inter-current conditions or other non-malignant illnesses that are uncontrolled or whose control may be affected by participation in this study
- Any patient who has urinary or faecal incontinence
- Status greater than or equal to 3
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 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 |
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实验性的：MR-Simulation
Patients will have 1 MRI scan appointment, using the Siemens Aera® (Siemens AG Healthcare, Erlangen, Germany) on the same day as their treatment planning CT scan.
The MR scan will be performed in the radiotherapy treatment position.
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MRI scan using the Siemens Aera® (Siemens AG Healthcare, Erlangen, Germany) on the same day as their treatment planning CT scan
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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 |
|---|---|---|
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Standard Operating Procedure (SOP) for MRI-simulation for prostate patients
大体时间：6 months
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Write a Standard Operating Procedure (SOP) for MRI-scanning of prostate patients in the radiotherapy treatment position so that their data can be used in the treatment planning for either in-direct or MRI-only planning
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6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Clinical Protocol for in-direct MRI planning for prostate
大体时间：6 months
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Write a clinical protocol for "in-direct" MRI planning of prostate external beam radiotherapy, whereby MRI data is used to define anatomical structures and these are translated onto the co-registered CT scan for treatment planning
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6 months
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Clinical Protocol for direct MRI-only planning for prostate
大体时间：18 months
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Write a clinical protocol for "direct" MRI-only planning of prostate external beam radiotherapy, whereby MRI data is used to define anatomical structures and also for dose calculation and setup verification
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18 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Simon Hughes、Guy's and St Thomas' NHS Foundation Trust
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年3月1日
初级完成 (预期的)
2023年6月1日
研究完成 (预期的)
2023年6月1日
研究注册日期
首次提交
2017年3月7日
首先提交符合 QC 标准的
2017年7月31日
首次发布 (实际的)
2017年8月3日
研究记录更新
最后更新发布 (实际的)
2022年3月18日
上次提交的符合 QC 标准的更新
2022年3月17日
最后验证
2022年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
MRI scan的临床试验
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