RecruitingNot ApplicableNCT02914067

Cognitive Biomarkers in Pediatric Brain Tumor Patients


Sponsor

Washington University School of Medicine

Enrollment

200 participants

Start Date

Oct 26, 2016

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 4 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study monitors cognitive abilities (thinking, memory, attention) in children with brain tumors, to better understand how brain tumors and their treatments affect mental function over time and identify early warning signs of cognitive changes. **You may be eligible if...** - Your child is between 4 and 18 years old - Your child has been newly diagnosed with a primary brain tumor (a tumor that started in the brain) - Your child is expected to live at least one year - Your child (and you as guardian) are willing to participate and can provide consent **You may NOT be eligible if...** - Your child has visual impairments severe enough to prevent completing computer-based tests - Your child is unable to cooperate with the testing Understanding cognitive effects of brain tumors helps doctors better support children's development and quality of life during and after treatment. Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERNeurocognitive testing
DEVICErsfcMRI

The imaging protocols will be a combined version of a standard of care (SOC) protocol with a research portion. The SOC portion of the pre-surgical scans includes a 3D T2-weighted (T2w) scans and 3D pre- and post-contrast T1-weighted (T1w) images, both at high resolution (1.0 mm3) for use in the intraoperative navigation system. This scan also includes a DTI portion for definition of fiber bundles of interest. The SOC portion of the post-surgical scans includes transverse FLAIR and post-contrast T1w images in all 3 planes. The research portion of the scan will be identical at all 3 time points and include 15 min of rsfcMRI during which the non-sedated subjects will be asked to stay still and awake while looking at a fixation cross


Locations(1)

Washington University School of Medicine

St Louis, Missouri, United States

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NCT02914067


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