Magnetic Resonance Imaging Biomarkers for Radiation-Induced Neurocognitive Decline Following Stereotactic Radiosurgery of Newly Diagnosed Brain Metastases: An Observational Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Radiation-Induced White Matter Injury
研究概览
简要总结
Brain metastases are a source of much morbidity and mortality in adults with primary solid malignant tumors. With improvements in systemic therapy that prolong survival but have limited central nervous system penetration, patients with brain metastases are at increasing risk of developing and experiencing long-term side effects from treatment of brain metastases. The overarching goal of this study is to better understand the determinants of RT-associated changes in white and gray matter function and associated neurocognitive decline.
详细描述
The proposed study aims to provide novel and useful information for clinicians, both to help predict potential neurocognitive changes following SRS, and as a possible guide for SRS treatment alteration, whether through adjustment of dose or beam arrangements in relation to white matter tracts. In this observational pilot study of 20 patients, the association between RT-associated brain injury and neurocognitive function will be quantitatively assessed longitudinally over one year following SRS. The study team hypothesizes that, over this time, (1) there will be radiation dose-dependent reductions in regional white matter tract integrity and reduction in functional connectivity in the default mode network of gray matter, (2) there will be measurable decline in neurocognitive function, and (3) there will be an association between severity of radiation-induced brain injury on MRI and magnitude of neurocognitive functional decline. This association will relate, in part, to the location(s) affected.
研究设计
- 研究类型
- 观察性
- 观察模型
- 其他
- 时间视角
- 前瞻性
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
- Histologic diagnosis of cancer
- Newly diagnosed brain metastasis being treated with SRS. Any extent of cranial disease permitted. Subsequent courses of SRS while on study permitted when clinically indicated.
- Patients are permitted to have undergone craniotomy and resection of metastasis/metastases if at least 1 other intact metastasis planned for definitive SRS is present. Receiving or previously received systemic therapy also permitted.
- Anticipated life expectancy at least 1 year
- Age ≥ 18 years
- Ability to read and comprehend written English and follow instructions in English
- Ability to provide informed consent
排除标准
- Previous radiation to the brain or head
- Previous malignancy - other than non-melanomatous skin cancer or cervical carcinoma in situ - and not disease-free for at least 3 years
- Previous severe head or brain injury
- History of a neurological disorder such as Epilepsy, Parkinson's, Alzheimer's, or Dementia
- Prisoners
结局指标
主要结局
Radiation-Induced White Matter Injury
时间窗: One year after SRS completion
Dose-dependent reductions in white matter integrity, as quantified by Diffusion Tensor MRI (DTI)-derived measures of change in diffusivity
次要结局
- Changes in Functional Connectivity(One year after SRS completion)
- Neurocognitive Changes(One year after SRS completion)
研究者
研究点 (1)
标识符
- NCT 编号
- NCT04073966
- 其他研究编号
- LCCC 1844
日期
- 首次提交
- (7年前)
- 首次发布
- (7年前)
- 主要完成日期
- (明年)
- 研究完成日期
- (2年后)
- 最近核实
- (2个月前)
- 最近更新
- (上个月)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否