RealMove (Lung): Assessing Tumour Motion With Dynamic MRI
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Difference in amplitude of the tumour motion, as assessed by dynamic MRI and 4D CT, respectively
研究概览
简要总结
The study aims to develop an improved method to tailor the geometric safety margin when treating with stereotactic body radiotherapy (SBRT), to avoid tumour cells being missed during irradiation and to limit the exposure of normal tissues as much as possible. Dynamic magnetic resonance imaging (MRI) is assumed to represent the tumour motion during the respiratory cycle more realistically, compared to 4-dimensional computed tomography (4D CT), thanks to its high temporal resolution and the possibility to image the motion over a longer period of time. Patients receiving SBRT for a pulmonary target located below the level of the carina are included in the study, and the hypothesis will be tested through a comparison of the tumour amplitude measured with each modality. Furthermore, the predictive value of the image series acquired at treatment planning, for the motion patterns observed at each treatment fraction, will be evaluated through repeated 4D CBCT acquisitions.
详细描述
In the current study, a 2D-cine MRI examination will be performed, in addition to the 4D CT examination that is standard for patients receiving radiotherapy for tumours in the thorax or abdomen. A subgroup of the study participants (referred to as the 4D CBCT subcohort) will also be required to perform a 4D CBCT examination at three treatment sessions. The main cohort consists of 95 subjects and the 4D CBCT subcohort of 55 subjects. The study does not involve any change in the treatment routine; rather, the study images are collected for retrospective analysis. Following each imaging session, the subject should fill out an anxiety questionnaire and their pulse will be measured, to give an indication of any anxiety which might influence the breathing pattern of the current session.
Clinical follow-up will be performed retrospectively by reviewing the participants' medical records. Progress, health status and treatment-related toxicity will be evaluated, up to 10 years after completed treatment.
The study objectives are:
- To evaluate dynamic MRI for characterising the respiratory-related tumour motion, compared to the current standard modality of 4D CT.
- To evaluate the variation in breathing motion at different times points.
- To evaluate the clinical outcome.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Accepted for SBRT treatment of one or more caudally situated lung targets (NSCLC or metastases), i.e. below the carina.
- •Age ≥ 18 years
- •Adequate clinical condition to maintain immobilised position for at least 30 minutes
- •Adequate Swedish skills and cognitive function to understand study information and to fill in the questionnaire
排除标准
- •Pregnancy or breastfeeding, or planned pregnancy or breastfeeding, during treatment
- •Contraindication for MRI examination
- •Otherwise incapable of participating in study
研究组 & 干预措施
Full cohort
All subjects are included in the same arm.
干预措施: Dynamic MRI (Other)
结局指标
主要结局
Difference in amplitude of the tumour motion, as assessed by dynamic MRI and 4D CT, respectively
时间窗: Over 3-4 weeks: twice pre-treatment, and three times during treatment
The two dynamic scans represent the tumour motion through different techniques. If the amplitude indicated by 4D CT is smaller than that indicated by dynamic MRI, the hypothesis is confirmed.
Difference in amplitude of the tumour motion, assessed at different times (using dynamic MRI and 4D CBCT)
时间窗: Over 3-4 weeks: twice pre-treatment, and three times during treatment
4D CBCT images are acquired at each treatment session, in treatment position. These will assess the stability of the breathing patter through the treatment course.
Difference in the structure of the probability density function, assessed at different times
时间窗: Over 3-4 weeks: twice pre-treatment, and three times during treatment
The breathing pattern is represented by a probability density function, indicating the regularity of the motion. The stability of this pattern through the treatment course will be assessed.
Difference in amplitude of the tumour motion, as assessed by dynamic MRI and 4D CT, respectively
时间窗: Over 3-4 weeks: twice pre-treatment, and three times during treatment
The two dynamic scans represent the tumour motion through different techniques. If the amplitude indicated by 4D CT is smaller than that indicated by dynamic MRI, the hypothesis is confirmed.
Difference in amplitude of the tumour motion, assessed at different times (using dynamic MRI and 4D CBCT)
时间窗: Over 3-4 weeks: twice pre-treatment, and three times during treatment
4D CBCT images are acquired at each treatment session, in treatment position. These will assess the stability of the breathing patter through the treatment course.
Difference in the structure of the probability density function, assessed at different times
时间窗: Over 3-4 weeks: twice pre-treatment, and three times during treatment
The breathing pattern is represented by a probability density function, indicating the regularity of the motion. The stability of this pattern through the treatment course will be assessed.
次要结局
- Anxiety during examinations of tumour motion(Over 3-4 weeks: twice pre-treatment, and three times during treatment)
- Overall survival(Up to 10 years after treatment)
- Progression-free survival(Up to 10 years after treatment)
- Grade ≥2 toxicity assessed by CTCAE v.5.0(Up to 10 years after treatment)
- Overall survival(Up to 10 years after treatment)
- Progression-free survival(Up to 10 years after treatment)
- Anxiety during examinations of tumour motion(Over 3-4 weeks: twice pre-treatment, and three times during treatment)