跳至主要内容
临床试验/NCT02914067
NCT02914067招募中不适用

Cognitive Biomarkers in Pediatric Brain Tumor Patients

Washington University School of Medicine2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2016年10月26日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
2
主要终点
Predictors of cognitive recovery in children as determined by multiplexed analyses of a combination of potential biomarkers across multiple modalities (rsfcMRI, structural MRI, NIH Toolbox, patient demographics, treatment information)

研究概览

简要总结

The investigators will focus on three cohorts of brain tumor patients aged, 4-18 years, to answer two critical questions: 1) Can the investigators acquire high quality data relevant to cognitive function during the peri-diagnostic period and, 2) can the investigators develop predictive models for cognitive outcomes using serial examination of functional imaging and cognitive function. Any patient with a newly diagnosed brain tumor aged 4-18 will be eligible for enrollment in cohort 1. Only patients with previously diagnosed tumors of the posterior fossa will be eligible for cohort 2. For cohort 3, eligible patients will include patients with a clinical diagnosis of posterior fossa syndrome with physical impairments that prohibit completion of the NIH Toolbox Cognitive Battery. The investigators have decided to expand the eligible tumor types to better capture the most significant deficit variability that can be caused by tumors outside the posterior fossa. Thus, this focus will provide a platform to analyze the impact that different tumor types and different standard treatments have on cognitive dysfunction. The rationale for inclusion of subjects on cohort 3 is that posterior fossa syndrome is one of the most cognitively devastating diagnoses following a posterior fossa surgery. The causes of posterior fossa syndrome and unknown and there are currently no interventions to improve symptoms. RsfcMRI would offer a novel and non-invasive assessment of posterior fossa syndrome patients by assessing connectivity within and outside of the cerebellum. Expanding the tumor eligibility will allow us to further explore the effect tumor location will have on cognitive testing and rsfcMRI. Here, repeated evaluations on and off therapy will provide the necessary data points to establish trajectories of cognitive development and recovery in this population.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
4 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Between 4 and 18 years of age, inclusive
  • Newly diagnosed primary brain tumor of any location and any histology
  • Life expectancy of at least one year
  • Able to understand and willing to consent or assent to the research proposed, along with consent of legal guardian(s) if applicable

排除标准

  • Presence of visual impairment to an extent that the patient is unable to complete the computer testing
  • Contraindication to MRI scan (i.e. due to cardiac pacemaker)
  • Programmable Shunt
  • Cohort 2 (150 patients will enrolled to this cohort. This may include some or all of the patients enrolled to Cohort 1.)
  • Inclusion Criteria:
  • Between 4 and 18 years of age, inclusive
  • Previous diagnosis of a posterior fossa brain tumor; patients who are either undergoing active treatment for posterior fossa tumor or who have completed treatment will be eligible for study enrollment
  • Life expectancy of at least one year
  • Able to understand and willing to consent assent to the research proposed, along with consent of legal guardian(s) if applicable
  • Exclusion Criteria:
  • Presence of visual impairment to an extent that the patient is unable to complete the computer testing
  • Contraindication to MRI scan (i.e. due to cardiac pacemaker)
  • Cohort 3 (20 patients will be enrolled to this cohort. This may include some or all of the patients enrolled to Cohort 1) Inclusion Criteria
  • Between 4 and 18 years of age, inclusive
  • Previous diagnosis of a posterior fossa brain tumor
  • Clinical diagnosis of post-operative posterior fossa syndrome
  • Inability to complete NIH Toolbox
  • Life expectancy of at least one year
  • Able to understand and willing to consent assent to the research proposed, along with consent of legal guardian(s) if applicable
  • Exclusion Criteria
  • Contraindication to MRI scan (i.e. due to cardiac pacemaker)
  • Cohort 4 (50 Patients will be enrolled to Cohort
  • This will include patients previously enrolled on Cohorts 1-3 above.)
  • Inclusion Criteria
  • Between 12-30 years of age, inclusive
  • Diagnosis of a brain tumor >3 years prior to study enrollment
  • Life expectancy of at least one year
  • Able to understand and willing to consent assent to the research proposed, along with consent of legal guardian(s) if applicable
  • Patient must be able to complete a 1 hour MRI scan without sedation
  • Exclusion Criteria
  • Contraindiciation to MRI scan (i.e. due to cardian pacemaker)
  • Presence of dental braces or programmable shunt
  • Patient requires sedation for MRI scan

结局指标

主要结局

Predictors of cognitive recovery in children as determined by multiplexed analyses of a combination of potential biomarkers across multiple modalities (rsfcMRI, structural MRI, NIH Toolbox, patient demographics, treatment information)

时间窗: Up to 27 months

As dictated by information theory, properly combining predictors across modalities must increase the accuracy of the prediction algorithm, unless a given modality contains no information about the question of interest (in this case, long-term cognitive outcomes).

Identify reliable peri-diagnostic estimators of cognition as measured by neurocognitive testing

时间窗: Peri-diagnostic period (from first presentation to 2 weeks post-diagnosis or two weeks post-op, whichever is later)

Identify reliable peri-diagnostic estimators of cognition as measured by advanced resting-state functional connectivity MRI (rsfcMRI) data

时间窗: Peri-diagnostic period (from first presentation to 2 weeks post-diagnosis or two weeks post-op, whichever is later)

Identify reliable peri-diagnostic estimators of brain function as measured by neurocognitive testing

时间窗: Peri-diagnostic period (from first presentation to 2 weeks post-diagnosis or two weeks post-op, whichever is later)

Identify reliable peri-diagnostic estimators of brain function as measured by advanced resting-state functional connectivity MRI (rsfcMRI) data

时间窗: Peri-diagnostic period (from first presentation to 2 weeks post-diagnosis or two weeks post-op, whichever is later)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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