MRI Study of Radiation-Induced Damage to White Matter and Blood-Brain-Barrier
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Change in Magnetic Resonance Imagining (MRI) with different radiation dose at different timepoints.
研究概览
简要总结
This is a study to determine if Magnetic Resonance Imaging (MRI) techniques can detect early changes in white matter (in the brain) and the blood-brain barrier resulting from radiation therapy.
详细描述
Patients will be assigned to one of two groups based on the type of radiation they will be receiving: whole brain irradiation or partial brain irradiation. Patients will undergo Magnetic Resonance Imaging (MRI) assessments, neurocognitive testing (Quality of Life and Neuropsychological assessments), and clinical evaluation.
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
- •Patients receiving partial brain irradiation for malignant or benign brain tumors (including low-grade gliomas, high-grade gliomas, malignant meningioma, pituitary adenomas, supratentorial meningioma, or craniopharyngiomas); or patients receiving whole brain irradiation for brain metastases.
- •Patients must be 18 years of age or older
- •Patients must sign a study specific consent form approved by the Institutional Review Board (IRB) of the University of Michigan prior to study entry.
- •Patients must have a neurological function class 1 or 2 with a Karnofsky performance status (a scoring system used to quantify general well being and quality of life on a scale of 100 to 0) of greater than or equal to
- •Patients must have an expected life expectancy of greater than 6 months.
排除标准
- •Patients with a history of major medical illness or psychiatric impairment which, in the investigator's opinion, will prevent administration of the protocol.
- •Patients who have had prior external beam irradiation to the brain or head/neck area that will lead to overlap of the radiation field.
- •Patients should have no contraindications to having a contrast enhanced Magnetic Resonance Imaging (MRI) scan.
- •Prisoners are excluded.
- •Pregnant women are excluded.
结局指标
主要结局
Change in Magnetic Resonance Imagining (MRI) with different radiation dose at different timepoints.
时间窗: Baseline, at 3 weeks on radiation therapy (RT) (partial brain irradiation only), last week of RT, 6 weeks post RT, 4 months post RT (whole brain irradiation only), 6 months post RT, 18 months post RT (partial brain irradiation only)
Linear mixed models will be used to relate Magnetic Resonance Imagining (MRI) changes and radiation dose.
次要结局
- Associate changes in Magnetic Resonance Imagining (MRI) assessments with changes in neurocognitive function and clinical symptoms, from baseline, and at different timepoints.(Baseline, 6 weeks post radiation therapy (RT), 4 months post RT (whole brain irradiation only), 6 months post RT, 18 months post RT (partial brain irradiation only))