Monitoring MRI Changes Before and During Radiotherapy Treatment of Brain Tumors
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- MRI parameters in the target volume
研究概览
简要总结
This study aims to evaluate anatomical and functional changes during RT for patients receiving fractionated RT for brain tumors. Anatomical changes during RT will be registered and analyzed and if needed the radiotherapy plan will be modified for the individual patient. This means that the "to be irradiated volume" will be modified according to the shape changes of the tumor. The functional MRI sequences will be used to evaluate what parameters, and at which time point, are important for radiotherapy outcome.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Primary brain tumor (WHO IV, GBM); treated with fractionated radiotherapy with or without preceding surgery. Systemic treatment is allowed before and during radiotherapy.
- •Brain metastasis (from a solid extracranial tumor) eligible for treatment with fractionated radiotherapy with or without preceding surgery. Systemic treatment is allowed before and during radiotherapy.
- •Also, postoperative patients with a macroscopic residual tumor lesion can be included (the diagnosis of residual diseases is defined by the treating neurosurgeon or on the MRI executed within 24 hours after the surgery, the diagnosis of residual macroscopic disease should always be confirmed during the neuro-oncology multidisciplinary meeting).
排除标准
- •Patients receiving Whole Brain RT (WBRT)
- •Patient with a poor kidney function (GFR < 30 mL/min; CKD 4 and 5; patients on dialysis and patients with acute kidney insufficiency)
- •None, doubtful or very small (<5 mm in its largest dimension) contrast enhancing lesion
- •Patients with a contraindication for MRI
结局指标
主要结局
MRI parameters in the target volume
时间窗: through study completion, an average of 3 years
functional MRI parameters (permeability, perfusion and diffusion) in the target volume before and during fractional radiotherapy treatment
anatomical variations in position, shape and size in the target volume
时间窗: through study completion, an average of 3 years
The difference is position shape and size in the target volume before and during fractional radiotherapy treatment. In case there is no macroscopic extension beyond the clinical target volume the new target volumes (gross target volume (GTV) and clinical target volume (CTV).) will also (but later) be delineated for analysis of volume changes, center of mass changes and distance measurements between the delineation on planning MRI versus repeated MRI.
次要结局
- the correlation between MRI parameters to the treatment outcome(through study completion, an average of 3 years)
- the correlation between anatomical variations and the treatment outcome(through study completion, an average of 3 years)