Diffusion-weighted MRI to Predict Treatment Response in Stereotactic Radiotherapy of CNS Metastases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Early changes in the tumor during and after completion of radiation therapy.
研究概览
简要总结
Stereotactic radiation therapy is an important and common method of treating brain metastases in patients with malignant disease. Today, however, there are no methods available to determine the metastasis' radiation sensitivity in advance and treatment responses can only be seen by changing of the size of the metastasis on conventional X-ray examinations, computed tomography (CT) and magnetic resonance imaging (MRI). Changes in the size of the metastases is something that is often seen weeks / months after treatment is completed. At Lund University Hospital, a new imaging technique, diffusional variance decomposition (DIVIDE), has now been developed. With this technique, the scatter in isotropic and anisotropic diffusion can be measured for each measuring point, which provides significantly more information about the properties of the tissue compared to current methods.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients prescribed stereotactic radiation therapy to the brain, where MRI imaging is included in the treatment preparations.
- •Cohesive remaining solid tumor component of ≥10mm.
- •Age ≥18 years.
- •World Health Organisation (WHO) performance status 0-1.
排除标准
- •Inability to decide for oneself on participation in the study.
- •Inability to understand the Swedish language.
- •Metastases close to the base of the skull.
- •Contraindications to conducting an MRI examination.
- •Contraindications to obtaining contrast media during MRI examination.
- •Expected survival less than 6 months.
- •Previous radiation treatment to the same site in the brain, i.e. current treatment is a rope radiation.
研究组 & 干预措施
Diffusion-weighted MRI to predict treatment response in stereotactic radiotherapy of CNS metastases.
Patients with brain metastases who will receive radiotherapy to the brain will undergo diffusion-weighted magnetic resonance imaging (MRI) at the same time as dose planning MRI is performed, after end of radiotherapy, and after 3 and 6 months after end of radiotherapy.
干预措施: Brain metastases radiation (Radiation)
结局指标
主要结局
Early changes in the tumor during and after completion of radiation therapy.
时间窗: Is evaluated after 6 months after end of treatment.
Evaluation done by MRI to see whether early changes in the tumor can be measured during radiotherapy and after 3 and 6 months after end of treatment.
Grade of radiation sensitivity to brain metastasis.
时间窗: Is evaluated after 6 months after end of treatment.
Evaluation done by MRI to see whether radiation sensitivity can be measured during radiotherapy and after 3 and 6 months after end of treatment.
Changes linked to treatment responses.
时间窗: Is evaluated after 6 months after end of treatment.
Evaluation done by MRI to see whether changes in the tumor can be measured during radiotherapy and after 3 and 6 months after end of treatment.
Differentiate between radiation damage (radionecrosis) and residual / recurrent tumor.
时间窗: Is evaluated after 6 months after end of treatment.
Evaluation done by MRI to see whether differentiation between radionecrosis and residual/recurrent tumor can be measured during radiotherapy and after and 6 months after end of treatment.
次要结局
未报告次要终点