PREselection of Patients at Risk for COgnitive DEcline After Radiotherapy Using Advanced MRI
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- Correlation cognitive failure and radiotherapy dose
研究概览
简要总结
Meningioma are slow growing and frequently occurring intracranial tumors, responsible for 33% of all asymptomatic intracranial tumors and 13-26% of all symptomatic primary brain tumors. The 10-year survival rate is 72%. A variety of treatment options is available for symptomatic meningioma including surgical removal with or without radiotherapy or radiotherapy alone. These therapies can have negative impact on cerebral functioning.
After high dose radiotherapy for primary or metastatic brain tumors 50-90% of > 6 months' survivors develop irreversible disabling cognitive decline leading to premature loss of independence, reduced Quality of Life (QOL) as well as significant economic burden both at the individual as societal level. Especially for patients with a good prognosis like benign meningioma, maintaining neurocognitive function is crucial. Understanding the mechanisms underlying radiation induced cognitive decline is complex and which brain areas to spare are an important subject of research.
Evaluation methods to assess cognitive function and predict cognitive decline are urgently needed, this will allow the development of optimized treatment strategies with the aim to preserve or even improve cognitive function in meningioma patients. Improvements in the field of neuroimaging techniques (i.e. advanced MRI techniques) have the possibility to identify areas susceptible to cognitive impairment. This allows in the future a more personalized radiation treatment by identifying patients at risk, by optimizing the radiotherapy dose to specific brain regions, that could eventually reduce or prevent, cognitive decline. Improvements in the field of radiotherapy for example by higher precision treatment such proton therapy have potential in obtaining these more individualized strategies.
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
- •Meningioma WHO I, grading based on pathology or radiological features
- •Age ≥ 18 years.
- •Karnofsky Performance Score 70 or above.
- •Ability to comply with the protocol, including neuropsychological testing and imaging.
- •Ability to understand the requirements of the study and to give written informed consent, as determined by the treating physician.
- •Written informed consent.
排除标准
- •Resection meningioma < 3mnd
- •Age < 18 years
- •Pregnancy
- •Any prior cranial radiotherapy
- •Any prior chemotherapy in the last 5 years
- •Contra-indication for MR imaging (i.e. metal implants, claustrophobia)
- •Any other serious medical condition that could interfere with follow-up.
- •Severe aphasia or language barrier interfering with assessing endpoints (i.e. completion of questionnaires or neurocognitive performance)
结局指标
主要结局
Correlation cognitive failure and radiotherapy dose
时间窗: 2 years after radiotherapy
Correlation between the delta cognitive failure score (baseline vs 2 years) and radiotherapy dose in cognition related brain regions (supratentorial brain, hippocampus left/right and anterior/posterior, cerebellum anterior/posterior).
次要结局
- RT induced cognitive change measured with extensive cognitive testing(2 years after radiotherapy)
- Correlation baseline imaging and patient specific parameters(2 years after radiotherapy)
- Correlation advanced MRI and PROMS(2 years after radiotherapy)
- Radiation susceptibility of organs by Normal Tissue Complication Probability (NTCP)(2 years after radiotherapy)
- Correlation advanced MRI and radiotherapy modality(2 years after radiotherapy)
- Sensitivity neurocognitive tests(2 years after radiotherapy)