Cognitive Outcomes After Brain Substructure-informed Radiation Planning in Pediatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 338
- 试验地点
- 4
- 主要终点
- Number of plans that meet substructure-informed planning constraints
研究概览
简要总结
The goal of this trial is to determine whether it is possible to minimize radiation dose to parts of the brain that are important for thinking and learning in children who require radiation to treat their tumor, and if this will help reduce neurocognitive (thinking and learning) impairments in these patients.
Patients with newly diagnosed brain or head and neck tumors who are having radiation therapy will have neurocognitive testing and MRI imaging (both research and for regular care) done as part of their participation in the study.
Survivors of childhood brain tumors who completed radiation therapy at least two years before joining the study, and have not had a recurrence, will have neurocognitive testing and research MRIs completed.
Healthy children will also be enrolled and have research MRIs done.
The researchers will use the radiation plan to determine how much radiation was delivered to different parts of the brain. The investigators will use the MRIs to determine how the normal brain is changing after treatment; and how this compares to patients who had standard radiation treatment or who never had a brain tumor. The neurocognitive testing will be compared among different groups to see how different treatment plans affect performance on neurocognitive tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 26 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Eligibility Criteria
- •aged 1 to <26 years of age
- •tumor must be located in the brain or adjacent to the brain including but not limited to nasopharynx, paranasal sinuses and orbit
- •treatment must include radiation therapy (either proton or photon)
- •patients must not have completed radiation therapy
排除标准
- •pregnancy
- •patients who are not able to undergo neuro-cognitive testing, including children lacking English comprehension or children with premorbid neurological/neurodevelopmental disorders such as Down's syndrome or autism
- •Eligibility Criteria
- •diagnosed with a brain tumor at <26 years of age
- •received radiation to the brain as part of therapy
- •time from radiation start to study enrollment is ≥ 2 years
- •there has not been disease recurrence from time of most recent radiation treatment to study enrollment
- •Exclusion Criteria
- •patients who are not able to undergo neuro-cognitive testing, including children lacking English comprehension or children with premorbid neurological/neurodevelopmental disorders such as Down's syndrome or autism
- •Eligibility Criteria
- •must be aged 5 to <26 years of age
- •must be able to complete research imaging without sedation
- •Exclusion Criteria
- •must not have any major psychiatric, neurologic or medical diagnosis
研究组 & 干预措施
Stratum A (new diagnosis, substructure informed radiation therapy)
Patients will undergo radiation therapy which has been planned according to dose constraints to specific brain substructures.
干预措施: substructure informed planning (Radiation)
Stratum A (new diagnosis, substructure informed radiation therapy)
Patients will undergo radiation therapy which has been planned according to dose constraints to specific brain substructures.
干预措施: Neurocognitive Testing (Other)
Stratum A (new diagnosis, substructure informed radiation therapy)
Patients will undergo radiation therapy which has been planned according to dose constraints to specific brain substructures.
干预措施: MRI (Diagnostic Test)
Stratum B (patients ≥ 2 years after standard radiation therapy)
Patients who completed radiation therapy under standard planning procedures ≥ 2 years ago.
干预措施: Neurocognitive Testing (Other)
Stratum B (patients ≥ 2 years after standard radiation therapy)
Patients who completed radiation therapy under standard planning procedures ≥ 2 years ago.
干预措施: MRI (Diagnostic Test)
Stratum C (healthy controls matched to Stratum A)
Healthy patients who are matched to Stratum A patients
干预措施: MRI (Diagnostic Test)
结局指标
主要结局
Number of plans that meet substructure-informed planning constraints
时间窗: 1 month
Number of plans that meet substructure-informed constraints (per protocol) divided by the total number of plans.
次要结局
- Cumulative incidence of local and distant tumor recurrence(up to 5 years after treatment)
- characterize longitudinal NIH toolbox scores in survivors of pediatric brain tumor who are ≥ 2 years post radiation(baseline to 5 years)
- compare the change in California Verbal Learning Test (CVLT) in patients whose radiation plans meet the dose constraints compared to those who do not for all patients in Stratum A.(baseline to 3 years)
- characterize longitudinal CVLT scores in survivors of pediatric brain tumor who are ≥ 2 years post radiation(baseline to 5 years)
- Fractional anisotropy values(baseline to two years)
- compare the change in NIH toolbox scores in patients whose radiation plans meet the dose constraints compared to those who do not for all patients in Stratum A.(baseline to 5 years)