An Exploratory Study to Assess the Feasibility of Incorporating MR in the Radiotherapy Pathway of Patients With Prostate Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Standard Operating Procedure (SOP) for MRI-simulation for prostate patients
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Written, voluntary, informed consent
- •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
排除标准
- •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
结局指标
主要结局
Standard Operating Procedure (SOP) for MRI-simulation for prostate patients
时间窗: 6 months
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
次要结局
- Clinical Protocol for direct MRI-only planning for prostate(18 months)
- Clinical Protocol for in-direct MRI planning for prostate(6 months)